Safe Patient Project
Real People, Real Medical Device Stories
FDA Needs More Post-Market Oversight Tools for
Problem Medical Devices Like Faulty Defibrillators
“Almost one year after being implanted, the defibrillator lead broke in half inside of my daughter Avery and caused her to have 9 defibrillation shocks. To any adult, this is scary. My three year old daughter Avery was convinced for months that there were monsters attacking her and was scared to move.” – Molly deGroh, mother of Avery, McHenry, IL
At the age of three, Avery deGroh was implanted with a defibrillator with a Medtronic Sprint Fidelis Lead due to a genetic heart arrhythmia. The lead connects the defibrillator directly to the heart and delivers an electrical shock when life-threatening heart rhythms occur.
On the day Avery was repeatedly shocked, her parents heard screaming from the basement where she was playing. Her mother picked her up and could feel her body jolting back and forth and was convinced she was having a cardiac arrest. Instead, the defibrillator lead was malfunctioning and sending unnecessary shocks to Avery’s heart. Five days later, Avery had to undergo surgery to replace the faulty device, which can be risky in young children. Avery was severely traumatized for months after the incident and was always on guard for another attack.
Since 2009, the FDA has received reports of close to 29,000 deaths or injuries from implantable defibrillators, by far the most for any device type. There have been two major recalls, in 2007 and 2011, of defective leads, the Medtronic Sprint Fidelis and the St. Jude Riata, after they had already been implanted in almost 350,000 patients. Patients with the device leads require close monitoring and face the prospect of needing to have them surgically removed.
Consumers Union urges Congress to adopt provisions from the Senate-passed version of the FDA User Fee Act that will help the FDA better protect patients when safety problems like the ones experienced by Avery and thousands of other patients harmed by faulty medical devices come to light. These provisions include implementing Unique Device Identifiers (UDIs) for high risk devices within two years; setting a deadline for when 522 post-market studies must begin; allowing FDA to order the completion of post-market studies as a condition of approving high-risk devices; and including devices in the Sentinel Initiative without removing important information about serious adverse events.
The House version of the bill does not contain these critical patient safety reforms.
For information contact Lisa McGiffert at lmcgiffert@consumer.org
Article Link: http://safepatientproject.org/posts/3277-3277
