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To the Editor: In his Commentary on the implications of recent implantable cardioverter defibrillator malfunctions for safety issues involving medical devices,¹ Dr Maisel inferred that St Jude Medical's method of estimating failure rates was flawed and would underestimate the true incidence of device failures. He based this statement on an editorial comment² referencing the device manufacturer's field advisory in 2000 on Trilogy pacemakers.

The Commentary stated that "a microprocessor anomaly was observed in 20 out of 144 000 Trilogy pacemakers." In the course of the standard evaluation of devices that were returned to St Jude Medical, an anomaly with the microprocessor-integrated circuit was detected. Potential manifestations included interrogation/programming difficulties, unexpected rate variation, abnormally high battery current reading, or a mode change, and the theoretically more serious problem of an inappropriate mode change to a single-chamber atrial pacing mode. Out of the total number, the mode change behavior had been identified in . . . [Full Text of this Article]

Paul A. Levine, MD
plevine@sjm.com

Gabriel Kohanyi
St Jude Medical CRMD
Sylmar, Calif

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