FDAnews Device Daily Bulletin


Dec. 1, 2005

Medtronic has advised physicians of a potential problem in some of its Sigma pacemakers, but the firm does not recommend replacing the devices. The overall incidence rate is "extremely low" and there have been no reported patient injuries or deaths related to this issue, Medtronic said.

The firm said it has determined that a potential separation of interconnected wires from the hybrid circuit may affect a small subset of Sigma series pacemakers. The anomaly may result in premature battery depletion, loss of telemetry or no pacing output, the firm said.

Medtronic said it has observed the wire separation in 19 devices, or about 0.05 percent of the affected subset of Sigma pacemakers. The estimated incidence of the anomaly for the affected devices is 0.17 to 0.30 percent over the ten-year projected life of the devices, it added. Roughly 28,000 Sigma pacemakers are subject to the advisory worldwide, of which approximately 6,650 are in the U.S.

The FDA may classify this communication action as a recall, the firm noted. Medtronic said it does not anticipate any material financial impact as a result of this notification.

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