Dublin – May 22, 2019 – Medtronic plc (NYSE: MDT) issued the following statement today regarding a Kaiser Health News story on the Sprint Fidelis Defibrillator Lead published on May 20, 2019. The statement can be attributed to Rob Clark, Chief Communications Officer, Medtronic.
“Kaiser Health News issued a story this week which stated Medtronic and the FDA worked together to ‘keep reports about the widely used device’s malfunction incidents – now totaling 50,000 – shielded from the public scrutiny.’ This statement, and therefore, the entire premise of the story is not true.
In reality, the FDA and Medtronic agreed in May 2008 that Medtronic would use the alternative summary reporting (ASR) process to report on Sprint Fidelis malfunctions associated with the recall of the device announced in 2007. Consistent with FDA guidance at the time, the FDA granted a ‘remedial action exemption’ within the ASR program which is granted when ‘the manufacturer has initiated reasonable and appropriate actions to mitigate the problem(s)’ and further reports will not ‘provide any significant new data.’ Simply put, the company could have provided 50,000 individual adverse event reports into the MAUDE database which all said the same thing or Medtronic could merely report in summary reporting fashion the 50,000 malfunctions. The Sprint Fidelis recall and reporting squarely met the intent of the remedial action exemption and so malfunctions were reported in that manner.
Most importantly, and not clearly stipulated in the Kaiser Health News story, is that these same malfunctions were reported to the medical community, patients and public. The Sprint Fidelis lead has been the most scrutinized, studied and reported on defibrillator lead in the history of our industry. Sprint Fidelis lead performance has been reported to the medical community and public through proactive communications beginning in 2007, 2008, 2009, and 2011 through formal updates as well as through our ongoing product performance reports, website and through other means. Medtronic’s lead product performance reports are publicly available, updated every six months and have a comprehensive description of device reliability on Medtronic’s cardiac rhythm products making these malfunction reports among the most comprehensive and transparent in the industry. These collective data sources – inclusive of post market registries, independent studies, and adverse event reports – provides the most reliable data regarding the performance and safety of Sprint Fidelis leads, as compared solely to adverse event data in MAUDE, which have significant and well-established limitations. To be clear, the 50,000 malfunctions identified in the Kaiser Health News story are reflected in our reporting on the ongoing performance of the device as reported in our lead performance reports.
To suggest the FDA and Medtronic somehow conspired to hide data on this product is completely untrue and unsubstantiated.
Medtronic strives to reduce or eliminate product malfunctions and events in all of our products, but when malfunctions do occur, we make every effort to inform regulators, the healthcare community and the public in a timely, transparent and compliant manner, and we are confident that we have done so and continue to do so with Sprint Fidelis.”
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