As a way of drawing attention to the need for further research into chronic pain, Medtronic Australia staff will be among those walking in the second annual “Walk against Pain”. The walk will take place at the Sydney Cricket Ground on Tuesday 2nd February prior to a “Battle of the Codes” (Rugby Union versus League) Twenty/20 fundraising cricket match scheduled for that night.

Walkers in lime green t-shirts including NSW Minister for Health & Medical Research Jillian Skinner will circle the perimeter of the SCG between 4 and 6pm. They will be awarded certificates of participation by Richie Benaud OBE and ABC Grandstand’s Jim Maxwell.

The Walk Against Pain is an initiative of the Pain Management Research Institute of the University of Sydney and Royal North Shore Hospital. More information can be found here.

“Medtronic’s co-founder Earl Bakken was fascinated by electricity from an early age.  Even as a toddler, he played with wires, cords, plugs and connectors – leading an uncle to warn his encouraging mother, “That boy’s going to electrocute himself someday”.  But his mother kept Earl supplied with spare parts, and he spent much of his suburban Minneapolis childhood wiring up his own creations, such as a private telephone system to a buddy’s house and a cigarette-smoking robot.

In high school, Earl drew plans for radios, rocket ships, and futuristic houses with all the electrical wiring in place, and was the self-described go to “nerd” who took care of the public address system, movie projector, and other electrical equipment at school.

But the pivotal moment in Earl’s life came somewhat earlier, at the age of eight or nine, as he sat watching a matinée showing of Boris Karloff’s 1931 Frankenstein – the story of a “mad scientist” who brings to life a man he has created in his laboratory.  At the time, Earl was fascinated by the fact that electricity could do more than light up a room. He was still too young to understand its implications for helping others; still too young a few years later when his pastor admonished him to use his scientific skills to benefit humankind.  Yet in retrospect, these two events sparked Earl’s transformation from tinkerer to healer.”

You can access an online copy, or order a hard copy of the Medtronic Mission book here.

Over the festive season I was sent a link to this fantastic advertisement made by the British Heart Foundation.

Featuring former soccer great and movie hard man Vinnie Jones, it demonstrates a really simple way to deliver CPR – no breaths required, and pushing hard and fast on the chest to the beat of Stayin’ Alive.

Well worth a watch.  Not only is it a great ad, but one day it might help you save a life.

The current media coverage does not relate to a new product hazard alert. The original alert was issued to doctors in October 2007 and several other communications have been made with doctors since then.

Patients should be assured that wherever issues are identified with products, doctors are provided with extensive information and recommendations in order to manage their patients appropriately. In the case of Sprint Fidelis, Medtronic ensured that treating practitioners were promptly provided information to allow them to exercise their clinical judgment as to whether and how to contact their patients about their leads.

Medtronic estimates more than 70,000 lives have been saved by implantable defibrillators over the past five years. Studies have shown ICDs to be 98 percent effective in treating dangerous arrhythmias that can lead to sudden cardiac arrest.

Medtronic is a clear industry leader in investing in long term monitoring studies and reporting those results for our products and responding quickly to provide information and recommendations to treating physicians and regulators where any issues are identified.

Medtronic Australasia is aware of and abides by, our obligations under TGA regulations. In the cases of Sprint Fidelis, Sigma and Kappa pacemakers, all actions have been undertaken in accordance with the TGA Uniform Recall Protocol for Therapeutic Goods (URPTG) guidelines and the TGA Adverse Events reporting requirements as per the Australian Regulatory Guidelines for Medical Devices (ARGMD).

Patients should be assured that wherever issues are identified with products, doctors are provided with extensive information and recommendations in order to manage their patients appropriately. If patients have concerns with regards to their condition their doctor is the appropriate person to discuss these concerns.

Implantable Cardiac Defibrillators (ICDs) are highly sophisticated, complex computers designed to prevent Sudden Cardiac Death (SCA). Deaths from SCA are estimated at more than 30,000 each year in Australia alone. ICDs are designed to provide painless pacing or life-saving shock therapy to stop fast or irregular heart beats, which can lead to SCA.

An ICD consists of a device implanted near the shoulder and one or more defibrillation leads connecting the device to the heart. The recall was issued globally as Medtronic found there was a small chance of fractures in particular locations on the Sprint Fidelis lead.

It is important to note that it was through our own product surveillance procedures that we discovered there was a small chance of fractures in the leads. Even though our surveillance revealed there was only a small chance of fractures, we made the decision to voluntarily notify the TGA and administer a recall notification.

The initial Sprint Fidelis recall letter was communicated in Australia in October 2007. Further patient management and lead performance updates were communicated on March 16, 2009 and April 4, 2011. The original recall action was a Hazard Alert while the last two were Safety Alert actions.*

All recall actions have been undertaken in accordance to the TGA Uniform Recall Protocol guidelines and the TGA Act (1989) and TGA (Medical Devices) Regulations (2002).

Medtronic is committed to keeping doctors regularly informed of Sprint Fidelis lead performance updates. We continue to actively monitor Sprint Fidelis lead performance and publish this data four times per year for doctors to review. Medtronic’s most recently published data showed that at 66 months post implant, 90.14 percent of Sprint Fidelis leads are performing appropriately. This data is based on data from more than 21,500 implanted leads – the largest data pool available on this lead. You can find this (and a summary of all available published data on Sprint Fidelis leads that we are aware of) at www.medtronic.com/fidelis.

In addition to regular lead performance updates the Independent Physician Quality Panel will continue to provide patient management recommendations to ensure patients currently implanted with the Sprint Fidelis lead continue to receive optimal care.

Patient safety and the quality of our devices are paramount to Medtronic. If patients have any questions about their Sprint Fidelis lead, it is advised they contact their doctor as they are in the best position to know how to manage patient care in light of specific health considerations.

*www.medtronic.com/fidelis is updated every six months with the latest lead performance and any updated recommendations. This website is for physicians and can be accessed at any time. Physicians may also opt to receive email notification when the website has been updated.

2. Please detail the actions taken relating to the leads in Australia and provide copies of any notices or alerts issued.

All recall actions have been undertaken in accordance to the TGA Uniform Recall Protocol guidelines. For information on notices issued, it is best to contact the TGA.

3. How many Australian patients had these devices?

Global figures reveal that as of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide. The number of patients implanted in Australia is approximately 1500.

4. How many of the devices have been removed? How many Australians still have active devices?

Medtronic does not have an accurate picture of this information because there is no requirement for a doctor to let us know they have explanted a lead.

Lead extractions are highly complex procedures. All surgical procedures have risks and while patient fatalities are rare, there is clearly risk associated with lead extraction. In fact, the risk of complications from extraction is greater than the risk of lead fracture. Physicians and their patients must weigh the risks and benefits of this or any other medical procedure in order to determine the most appropriate course of action.

5. How many adverse events have there been and what do the adverse events include?

Any adverse events have been reported to the TGA as per the TGA Adverse Events Reporting requirements.

The recall was issued as Medtronic found there was a small chance of fractures in particular locations on the Sprint Fidelis lead. There was a chance this could lead to the ICD delivering inappropriate shocks to the patient.

Medtronic has provided physicians and their patients with a tool called Lead Integrity Alert. Lead Integrity Alert has been shown to provide most patients with up to three days advance notice prior to receiving an inappropriate shock due to lead fracture through an audible alert. Patients can have the Lead Integrity Alert uploaded to their ICDs during their device check visits.

6. How many deaths have there been in Australia that can be connected to recalled devices? How many deaths worldwide?

7. Please provide a detailed explanation of how the Medtronic Sprint Fidelis leads came to be approved in Australia.

The Sprint Fidelis Lead was approved in Australia by the TGA, having undergone a Full Conformity Assessment Audit by the TGA office of Device Authorisation (Formally known as the Office of Blood, Tissues, and Devices).

To be precise, the Fidelis lead underwent a Full Quality Assurance Procedures (Part 1) including Examination of Design (Part 1.6) as per Schedule 3, Part 7, Clause 7.5 of the Declaration of Conformity legislative Reference (Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations)).

• This type of Conformity Assessment typically encompasses audit of the design, production, packaging, labelling, and final inspection of a medical device.
• In this assessment, the manufacturer is expected to implement a full quality management system (that is all clauses of ISO 13485 including clauses 7.3 and 7.5.2) and arrange for the quality management system to be audited by the TGA or EU Notified Body.
• The TGA or EU Notified body also assesses the manufacturer’s technical documentation (design dossier) for the Sprint Fidelis including clinical evidence to assess the compliance with the Essential Principles of Construction and Design. The assessment is based on the design and development records produced under the manufacturer’s quality management system and compiled/summarised into a ‘design dossier’.
• An Australian Declaration of Conformity in accordance with clause 1.8 of Schedule 3 of the Regulations was also prepared and submitted by the manufacturer.

This is the most rigorous assessment audit that any drug/device combination product approved by the TGA can undergo.

8. Does the failure of these leads indicate a serious failure of approval processes for devices in Australia?

Patient safety and the quality of our devices are paramount to Medtronic. We do not believe there is any evidence that current regulatory processes in Australia are systemically failing. The current system balances the need to get effective new treatments to patients in a timely manner, while ensuring that these technologies meet high standards of safety and efficacy. Mechanisms to quickly identify products that are underperforming and quickly remove them from the market and alert treating doctors provide the best protections for patients. This is what occurred in this case.

Over-regulation particularly in the pre-market area impacts negatively the time to market for medical devices, thereby limiting the ability for patients to access life-saving and life-enhancing medical technology. There is no evidence that increasing pre-market regulatory requirements is effective enough to outweigh the negative consequences of these delays.

The TGA monitors compliance in the manufacturing of devices, which continues after the marketing approval is granted, supported by compulsory adverse event reporting requirements for sponsors and manufacturers as well as a voluntary problem reporting system developed for users of medical devices, including clinicians, hospitals and patients.

Medtronic is aware of, and abides by, our reporting obligations under the TGA.

9. Were Australian patients personally notified of the recall by Medtronic? It is understood US patients were personally notified by Medtronic by letter – why didn’t this occur here, and was there any requirement for this to occur?

All recall actions have been undertaken in accordance to the TGA Uniform Recall Protocol guidelines.Personal notification of patients is not a part of the Uniform Recall Procedure for Therapeutic Goods (URPTG) requirements. It is correct that US patients were personally notified by letter, however it must be noted that the FDA is the ruling health regulatory body in the US, with differing protocols and procedures to the TGA.

As per the TGA’s Uniform Recall Protocol guidelines for these types of products it is the patient’s treating doctor that is notified and not the patient directly. As part of this procedure Medtronic supplies a list of all patients on record with an affected device to their treating doctor for follow up.

Detailed information was provided to doctors, since they are in the best position to know how to manage patient care in light of specific health considerations. Regular updates are provided to doctors, including regular lead performance updates and patient management recommendations from Medtronic’s Independent Physician Quality Panel to ensure patients currently implanted with the Sprint Fidelis lead continue to receive optimal care

10. Does Medtronic know if all Australian patients are aware of the recall, and was enough done to notify patients?

Whenever a healthcare professional is notified of a Field Corrective Action (FCA) Hazard Alert (notification distributed on October 2007) the doctor is required, as per TGA Uniform Recall Protocol guidelines, to acknowledge the alert letter by signing and returning it to Medtronic. Confirmation of receipt is then submitted to the TGA.

Medtronic is committed to keeping doctors regularly informed of Sprint Fidelis lead performance updates. We continue to actively monitor Sprint Fidelis lead performance and publish this data four times per year for doctors to review. In addition to regular lead performance updates the Independent Physician Quality Panel will continue to provide patient management recommendations to ensure patients currently implanted with the Sprint Fidelis lead continue to receive optimal care.

All recall actions have been undertaken in accordance with the TGA Uniform Recall Protocol guidelines. For information on notices issued, contact the TGA.

We encourage patients with Sprint Fidelis leads to contact their doctor’s office with any questions about their leads or the information in this letter.

11. Is Medtronic aware of any advertisements or media reports relating to the withdrawal of the leads in Australia?

The persons to be notified and the manner in which they are to be notified is determined by the TGA recall coordinator as per the TGA Uniform Recall procedure. Advertisements were not considered to be appropriate for this recall by the TGA.

In addition to healthcare professionals being notified of the recall and provided with regular updates, there has been widespread coverage of this recall globally.

12. Has any compensation been paid to Australian patients? If so how much and to how many patients?

Patient safety and the quality of our devices are paramount to Medtronic. Due to privacy and confidentiality reasons we cannot discuss particular patient cases or claims.

13. Have any legal claims been initiated by Australian patients and if so what has been the result?

Patient safety and the quality of our devices are paramount to Medtronic. Due to privacy and confidentiality reasons we cannot discuss particular patient cases or claims.

On receiving the draft Assessment Report from MSAC, Medtronic Australasia identified several concerns related to selective reporting, inaccurate clinical assumptions and data misinterpretation which fundamentally compromised the integrity and accuracy of the Report. When Medtronic sought details of the MSAC internal review process (as recommended by the DoHA initiated Review of Health Technology Assessment in Australia*), we were informed that there is currently no formal appeal process.

Of particular concern was the comparison of balloon kyphoplasty with vertebroplasty, which we believe is inaccurate.

While both procedures involve the use of bone cement, there are important differences. Balloon kyphoplasty is a surgical procedure designed to restore vertebral height, correct angular deformity and stabilize the spine. Vertebroplasty is designed to stabilize the spine, but does not aim to correct the deformity.

According to the 2005 MSAC Assessment report, an estimated 2,000 Australians per year will experience a symptomatic vertebral fracture. Kyphotic deformity (a rounded or humped back) and progressive bone weakness increase the risk of additional fractures. In cases of pronounced kyphosis, the ability to breathe, walk, eat, or sleep properly may be adversely affected.

The body of evidence supporting balloon kyphoplasty continues to grow. However, several recent, clinically relevant publications were not considered during the MSAC evaluation.

It is also important to note that the well-known clinical studies by Buchbinder etc all. 2009; and Kallmes et al. 2009 do not relate to balloon kyphoplasty. These studies found that there was no beneficial effect of vertebroplasty when compared with a sham procedure.

Medtronic Australasia is disappointed in the outcome of the MSAC assessment and will continue to explore options to make balloon kyphoplasty available to Australian patients.

*Review of Health Technology Assessment in Australia December 2009 (http://www.health.gov.au/internet/main/publishing.nsf/Content/00E847C9D69395B9CA25768F007F589A/$File/hta-review-report.pdf)

To qualify for this prestigious list, companies must appear on at least five national Great Place to Work lists, have at least 5,000 employees worldwide, with 40 percent or 5,000 employees or more working outside of the company’s home country.  In 2011, Medtronic was named to the Best Workplaces lists in Canada, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain and the European Union.  

“Through innovation, we strive to create an environment where talented people want to work.  The people at Medtronic are truly unique and it is their commitment to living Medtronic’s Mission every day that makes this recognition possible,” said Caroline Stockdale, senior vice president and chief human resources officer at Medtronic.  “Medtronic will continue to accelerate growth in countries worldwide.  This is a great acknowledgement of our strength in the global workplace.”

The “World’s 25 Best Multinational Workplaces” list is compiled for FORTUNE by the Great Place to Work Institute.  This year more than 350 companies participated.  Three-fourths of the list’s scoring is based on an employee survey and a questionnaire about the organization and one-fourth is based on the number of countries and the percentage of employees that participated in a national Great Place to Work Best Workplaces competition.

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

The hackers targeted insulin pumps that function properly and meet all quality standards. Product quality and user safety are of utmost importance to Medtronic. The company is deeply concerned that insulin pumps can possibly be hacked. Medtronic believes that the likelihood of an actual hack is low but takes the safety experts’ warning signals very seriously and has begun working toward a solution. Medtronic has received no reports from patients.

Medtronic takes patient safety and device security very seriously and we appreciate the security community bringing forward new information on the possibility of manipulating or “hacking” our insulin pumps.  We have been increasing our focus on the prevention of tampering with our products and look forward to working with the security, healthcare and diabetes communities to develop ways to better protect patients from the risk of tampering, which is necessary to keep pace with a new and rapidly evolving technology landscape.

We have taken a number of steps to address this matter including conducting an indepth risk/benefit analysis to clearly assess the potential risk, evaluating the best encryption and security technologies for incorporation into our products and design process, and finally, committing to establish an industry working group that engages relevant stakeholders from the diabetes, healthcare and security community to develop new approaches and best practices to device security.

Because insulin pumps are widely used by patients with diabetes for tight blood sugar control and lifestyle flexibility, we are also working to assure both patients and doctors that at this time we believe that the risk is low and the benefits of the therapy outweigh the risk of an individual criminal attack.

Once a simple communication device, the modern smart phone is now being used by doctors to save lives.