Boston Scientific Issues Warning About Malfunctioning Defibrillators

Boston Scientific Corp. recently announced, a malfunctioning wire in Cognis and Teligen defibrillators may result in an abnormal or unnecessary shock, causing serious medical injuries to patients.

Defective Medical DevicesBoston Scientific introduced the defibrillators last year in an attempt to grab market share from other device makers. The company expected sales from the two defibrillators to fast track growth this year. The safety warning, sent to cardiologists, seems to have put a halt on the company's plans, in addition to causing concern to thousands of patients who are implanted with the Cognis and Teligen defibrillators. The company says about 34,000 units have been sold since their introduction. The problem, however, is restricted to about 8,000 of these devices that come with respiratory sensors. The wires that connect the defibrillator to the heart are prone to malfunction which can result in one of two situations:

  • The device may fail to operate properly, resulting in failure to emit a lifesaving electrical jolt to the heart when an abnormal cardiac rhythm is detected.
  • The device may deliver an unnecessary electrical shock to the heart, resulting in severe pain and cardiac injuries.  

Wire problems with defibrillators tend to increase as the device gets older. The Cognis and Teligen defibrillators however are a relatively new entrant into the $11 billion defibrillator market. This is why the announcement, which warns of the device's susceptibility to early malfunction, surprised so many defibrillator experts. If these warnings seem all too familiar, it is because medical injury lawyers and patients who suffer from cardiac arrhythmia remember the thousands of injuries and 13 deaths caused by Medtronic’s malfunctioning defibrillators in 2007.

Defective Defibrillators

Considering the number of problems linked to these devices, it is fair to assume that there could potentially be malfunctions in defibrillators manufactured by other companies also. Cardiac defibrillator devices have been a blessing for thousands of patients who suffer from heart problems. However, manufacturing companies have been reluctant to inform the public about problems with the devices. To make matters worse, the U.S. Food and Drug Administration, which is supposed to screen devices thoroughly before approving them for marketing, has been slow to warn patients.

If you've been injured by the use of a defective defibrillator or other medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case.