Sigma implantable pulse generators (IPGs) dual Chamber Pacemaker, models SD203, SD303
FDA Recall Z-0534-06 · Posted 2006-02-18
Recalling FirmMedtronic Inc. Cardiac Rhythm Managment
Recall StatusTerminated
Product CodeDXY
Date Initiated2005-11-29
Date Terminated2007-01-04
Product Quantity3,588
Reason for Recall
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.
Firm Action
Press Release was issued 11/29/05. Hospital/physician letters sent via registered mail on 11/29/05 for delivery on 12/01/05. Unimplanted devices are being retrieved. The Physician letter describes the issue, root cause, the probability of reoccurrence and provides recommendations. A list of affected serial numbers that the physician is following or has implanted is attached to the letter. The letter also provides medtronic's website in which regular updates on the ongoing actual performance are listed in their Product Performance Report. Medtronic is providing a replacement device should the Physician and patient elect to replace the affected implanted device.
Root Cause
Other
Distribution Pattern
Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.