The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
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
I do not know what a UDI is and do not find an explanation in this article. Thus hard to support this point of view. Please do better editing so your point is not lost.
the lead broke inside her body, don’t need any more information than that, a faulty wire as in anything else causes shock or fires in a house and shocks in the body!
It might help if you read the article again, in the last paragraph after the bold words, on the second line in normal type it tells you what UDI stands for, Unique Device Identifier.
Did you find it?
Cheers.
A UDI or Unique Device Indentifier is basically a serial number or other way of identifying and keep track of each individual medical device.
http://en.wikipedia.org/wiki/Unique_Device_Identification
It would help with device recalls and telling devices apart from counterfeit devices.
Hi Kay, it’s Daniela with Consumers Union’s Safe Patient Project. UDI means Unique Device Identifier. It’s similar to a car’s VIN number. UDIs are key to tracking devices once they’re on the market and key to notifying patients and doctors when safety problems occur.
Had a Medtronic neurostimulator implant placed inside my spinal column and the generator in my left buttock – excruciating pain with surgery as they would not believe me that the epidural did not take although I could move both legs and swing them, etc – so went thru surgery w/o anesthesia. Despite watching the video and reading the brochure PRIOR to the procedure stating it would BE helpful for my LOW back chronic pain; I received a wallet card and another booklet AFTER the surgery that CLEARLY states “Will NOT be helpful in low back pain patients” – thanks! Then, after 2 weeks went into neurosurgeon as I was only getting 50% effect and learned that only one-half of the electronics were working – the reps comment from Medtronic “Well, look at this way, the battery will last twice as long” – NEVER went back and have not turned the thing on in years. Waiting to have another back surgery and then will have it ALL removed at the same time; someone NEEDS drastic oversight on MEDTRONICS especially since they seem to have the highest recall rate of all the medical equipment companies. Would not recommend ANY of their products to ANYONE. Their brochures BEFORE and AFTER completely differ – I kept BOTH just in case a lawsuit should pop up and I will GLADLY join that class action suit wholeheartedly. Our lives are in their hands, and their charge for this piece of equipment – a mere $85,000 to my insurance company and it doesn’t even work!
This is so heartbreaking and stresses out the child not knowing what is happening to her. I too am suffering with several implants and having probs with it. I wou8ld like more oversight being met by our government so we don’t have to suffer. I can see how this is traumatizing her and it would lead her to have a huge fear of docs and procedures like it does me. This can be corrected by better measures.
UDI is explained in the article in the second to last paragraph, second sentence; “Unique Device Identifiers (UDI’s).