The US FDA and Guidant Cardiac Rhythm Management (a subsidiary of Boston Scientific) have notified healthcare professionals via letter regarding the potential for malfunction associated with a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), and implantable cardioverter defibrillators (ICDs).

The FDA has received several reports of device malfunction due to failure of a low-voltage capacitor from a single-component supplier, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program. Although there have been 2 cases of pacemaker patients experiencing syncope due to loss of pacing output, no patient deaths have resulted.

Affected pacemaker families include Insignia (model numbers 0482, 0484, 0485, 0882, 0982, 0985, 0986, 1190, 1192, 1194, 1195, 1198, 1290, 1291, 1292, 1294, 1295, 1296, 1297, and 1298) and Nexus (models 1325, 1326, 1328, 1390, 1392, 1394, 1395, 1398, 1426, 1428, 1432, 1466, 1467, 1468, 1490, 1491, 1494, and 1495). Patients with these devices may experience a loss of output or telemetry or premature battery depletion.

CRT-P families include the Contak Renewal TR (models H120 and H125) and TR2 (models H140 and H145).

Affected ICD families include the Ventak Prizm 2 (models 1860 and 1861), Vitality (models 1870, 1871, T125, T127, and T135), and Vitality 2 devices (models T165, T167, T175, and T177). The FDA notes that patients with these ICDs may experience inappropriate sensing or premature battery depletion.