Boston Scientific just issued a warning for its Cognis and Teligen implantable defibrillators following a patient death. Electrical malfunctions in the cardioverter defibrillators (ICDs) are believed to be the culprit in adverse events linked to the devices that include one death.
Boston Scientific cited “an identifiable pattern of malfunction,” wrote MassDevice. Analysis of the device revealed a transformer malfunction. The defect, Boston Scientific said, is that “A transformer is used in all implantable defibrillators to multiply the low voltage of the battery (~3 volts) to the high voltage of a shock (~800 volts). Transformer malfunction has occurred during a high voltage charging cycle (a capacitor reform or a therapeutic shock).” The malfunction could lead to a loss of shocking therapy and could cause rapid battery depletion and loss of programming and remote monitoring capability, explained Mass Device.
Four other patients reported “a sudden heating sensation at the implant site, likely due to rapid battery depletion,” according to the warning, explained MassDevice. To date, Boston Scientific has confirmed 26 malfunctions of roughly 233,000 Cognis and Teligen ICDs implanted worldwide, said MassDevice. Boston Scientific noted that the longer the patient has had the ICD, the less likely the device is to malfunction.
The Cognis and Teligen models involved are:
- Cognis CRT-D N118/N119/N120/P106/P107/P108
- Teligen DR ICD E110/E111/F110/F111
- Teligen VR ICD E102/E103/F102/F103.
All Cognis and Teligen ICDs use the faulty transformer component.
Earlier this year, we wrote that Boston Scientific’s Guidant unit stated that it would pay a record criminal penalty for withholding safety information about its defective ICDs from federal regulators. The defibrillators at the center of the U.S. Justice Department’s (DOJ) criminal prosecution of Guidant Corp. were linked to the deaths of 13 people.
The $296 million settlement also called for Boston Scientific to serve three years’ probation. The $296 million penalty is believed to be the largest criminal penalty ever imposed in a medical device case.
The DOJ probe that resulted in the proposed settlement centered on three Guidant ICD devices that had the potential to short-circuit: The Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). According to the charges filed in federal court, Guidant violated the Food, Drug and Cosmetic Act by concealing information from the U.S. Food & Drug Administration (FDA) about catastrophic short-circuiting failures in the three models. The company discovered problems with one of the products in 2002 and became aware of problems with two others in 2004, the department said. Three safety alerts were issued about these defibrillators in June 2005. The FDA later determined these were Class I recalls, which are the most serious type of device recall because there is a reasonable change the devices could cause serious health problems or death.
Boston Scientific acquired Guidant in 2006. In 2007, the device maker agreed to pay $240 million to settle more than 8,000 lawsuits claiming Guidant hid defects in defibrillators, which are devices that shock the heart back into regular rhythm.