Barely out of the starting block with their new model of implantable cardiac defibrillators, Boston Scientific issued an advisory (pdf) on their new line of COGNIS CRT-D and TELIGEN implantable cardiac defibrillators. TELIGEN ICD products, model numbers E102, E110, F102, F110 and COGNIS CRT-D products, model number N106, N107, N118, N119, P106, P107 are affected.
This line of ICD's has a sensor that detects the patient's respirations which can be programmed ON or OFF. This advisory only affects the devices with this respiratory sensor programmed ON. It seems at this setting, certain potential right ventricular lead complications such as chronic lead fracture and acute lead connection issues may cause additional oversensing, thereby increasing the probability of the device failing to pace appropriately or giving inappropriate shocks. The company recommends programming the sensor to OFF, thereby correcting the problem.
More information and links to Boston Scientific's physician letter can be obtained from the Heart Rhythm Society's website.