pacemaker

Devices & Diagnostics

St. Jude issues ‘Dear Colleague’ letter regarding older pacemakers during surgery

On 29 January 2014, St. Jude Medical issued a “Dear Colleague” letter regarding their review of incident reports on older-model pacemakers (Affinity, Entity, Integrity, Identity, Sustain, Frontier, Victory and Zephyr models) that occasionally dropped their output voltage during surgical electrocautery. (Here’s a publication describing two such cases.) Several issues regarding this advisory letter are troubling. […]

Devices & Diagnostics

FDA advisory panel recommends Medtronic expand CRT device indication to treat patients with AV block, reduced heart function

In a tight vote Tuesday, a U.S. Food and Drug Administration Circulatory Systems Device Advisory Panel recommended Medtronic‘s (MDT) CRT devices are beneficial for biventricular pacing when treating patients with atrioventricular block and left ventricular systolic dysfunction. The vote that the overall benefits outweigh potential risks–four recommend, three no and one abstain–was based on clinical […]