st. jude

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. […]