Medtronic in October 2007 disclosed problems with an electrical lead that connects to defibrillators that had caused malfunctions in hundreds of patients and possibly contributed to the deaths of five patients.
Medtronic urged an estimated 235,000 patients who have the lead, or wire – known as the Sprint Fidelis and used since 2004 – to see their doctors to check that the lead had not developed a fracture. The company estimated that such a fracture would occur in 4,000 to 5,000 patients within 30 months after the device was implanted.
The concern was that such a malfunction could cause a defibrillator to misread heart-rhythm data and that in turn could result in the device delivering an unnecessary electrical jolt to a patient’s heart or the failure to deliver such a jolt at a critical time when it is needed by a patient.
Kline & Specter, PC, with more than 40 attorneys,several of whom are also doctors, handled Medtronic defibrillator cases and has the experience to litigate product liability cases.
Guidant in June 2005 voluntarily recalled almost 50,000 defibrillators because certain models contained a flaw that caused some units to short-circuit and malfunction, resulting in at least two reported deaths and potentially many more. The company has offered free replacements, which requires surgery, but has not said that removal or replacement is necessary.
The New York Times reported that Guidant failed to alert physicians or patients for three years about the problem in some of the devices implanted in an estimated 24,000 people.
The problem with the Guidant defibrillators came to light in connection with a defibrillator, which is intended to shock a faltering heart back into a normal rhythm, implanted in a 21-year-old Minnesota college student who had a genetic heart disease. The student died.
According to The Times article, Guidant acknowledged that the student’s defibrillator had short-circuited and the company later said it was aware of 25 other cases in which that model of defibrillator – a Ventak Prizm 2 Model 1861 – had the same defect. Later reports identified at least 45 failures in Guidant defibrillators and at least two deaths.
Additionally, in April 2007, Guidant recalled some 73,000 implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) because of a defect that shortened battery life.
The Welch Allyn defibrillators were found, according to the company, to "experience failure or unacceptable delay" due to a faulty electrical connection inside the device. Welch Allyn recalled 580 of the automatic external defibrillators, most sold in the Unites States.
To read a news article on faulty defibrillators, click here.
* Defibrillator is commonly misspelled defibillator, defribilator, defibillator and defibrillater.
- Medtronic Inc. to pay over $75 million to settle thousands of lawsuits that allege the medical device maker hid defects in its defibrillators, according to media reports.(Full story)
- Tighten post-market surveillance of pacemakers, defibrillators, says Heart Rhythm Society