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Sprint Fidelis Lead

5 December 2011

On Dec 4 the Sunday Mail published an article in relation to the Sprint Fidelis lead which was withdrawn from the market in October 2007. You can read Medtronic’s full response below:

1. Were Medtronic Sprint Fidelis leads recalled in Australia? When were they recalled, and why? Did the recall occur at the same time as the recall in the US?

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?

At the time Medtronic Inc made the announcement that Sprint Fidelis lead related deaths had risen to 13, an Australian patient was included in this number as lead fracture could not be conclusively ruled out as related to their death.

Since then, further analysis of the facts surrounding the death suggest that the lead fracture was unlikely to have been related to cause of death. However, in the interest of full disclosure we have not revised the number of patient deaths downwards.

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.

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