A device designed to monitor cardiac patients at high risk and provide emergency treatment when necessary has been the subject of an FDA recall notice. Some units of the device, the Zoll LifeVest 4000, may fail to operate as intended, putting patients at risk of sudden death.
There have also been scattered reports of other problems with the LifeVest, including one patient who was jolted thirty-nine times during a single cardiac event and an eleven-year-old girl who was subjected to multiple false alarms from the device and may have been burned by it.
The LifeVest 4000 is a recent model in a line of wearable cardioverter defibrillators that first came onto the market in 2002. In basic terms, the device is a cardiac defibrillator similar to those used in hospitals and the AED devices now frequently found in public places. It can deliver an electric shock to correct a dangerous heart rhythm problem.
Implantable defibrillators have been approved for use for more than thirty years. Instead of requiring a surgical implant, the LifeVest allows a patient to wear the defibrillator externally in a vest that includes sensors to monitor heart function and, in the event of a dangerous development, provide automatic defibrillation. The device is typically prescribed to patients who have a temporary need, or to those who need a defibrillator device but can’t undergo surgery for some reason.
Unfortunately, the device has run into some trouble. The recall, in January, highlights a particular error condition that appears to make the vest nonfunctional. That problem, according to FDA documents, has resulted in one death.
The total number of devices believed to be putting patients at risk is relatively small. Around 25,000 of the devices have gone into use in the United States, and the FDA estimates suggest that fewer than one hundred could be causing trouble. Nonetheless, any patient who receives a specific error code on their vest is urged to contact the manufacturer immediately.
While some praise this device, others have been skeptical. In fact, there has been no clinical trial data proving that the LifeVest is effective, despite it being on the market for nearly two decades.
The results of one study will be released later this year, but some physicians have gone on the record stating their belief that the device has no value and has been pushed on patients without good information.
If a defective medical device such as the LifeVest has caused you harm or distress, it’s your right to pursue a remedy in civil court. An important first step is to discuss your situation with an experienced defective medical product attorney to understand your options.
The team at Craig Swapp & Associates has helped many clients with this kind of case, and we offer a free consultation. Call 1-800-404-9000 or reach us online through the form below to schedule an appointment. You can also launch the chat feature from any page of this website to learn more.