The Natick-based medical devices monolith said in a March 23 letter to doctors that faulty wiring in some of its Cognis and Teligen devices misfired, causing what it termed “inappropriate” shocks to patients.
Up to 8,000 of the 34,000 other patients implanted with the devices could be at risk, the company said. No deaths have been reported because of the malfunctions and there are no recall plans.
A Boston Scientific spokesman said the possibility of inappropriate therapy can be eliminated if doctors switch the devices’ wireless sensors off.
The problems with the devices could increase “the probability of inappropriate therapy,” the letter said, adding that five to eight “inappropriate” shocks in a row could leave them unable function normally during arrhythmia episodes.
The Cognis and Teligen defibrillators, touted by Boston Scientific as the smallest and thinnest such products available, are designed to help regulate the heart by delivering a small shock when they detect an irregular heartbeat.