Class 2 Device Recall Sigma Pacemaker

• Date Initiated by Firm: November 29, 2005
• Date Posted: February 18, 2006
• Recall Status: Terminated on January 04, 2007
• Recall Number: Z-0536-06
• Recall Event ID: 34093
• PMA Number: P980035S002
• Product Classification: Implantable Pacemaker Pulse-Generator - Product Code DXY
• Product: Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.
• Code Information: Not all serial numbers within these ranges are affected. The specific serial numbers of affected devices may be found online at http://SigmaSNList.medtronic.com. Model SVDD303: serial no. PJD183400H - PJD183447H, PJD186130H - PJD186199H, PJD188418H - PJD188519H, PJD430299H - PJD430332H, PJD441378H - PJD441396H, PJD442436H - PJD442448H, PJD445371H - PJD448139H, PJD675113S - PJD675193S, PJD675694S - PJD676809S, PJD677182S - PJD677945S, PJD678157S - PJD686906S, PJD730001S - PJD744349S.
• Recalling Firm/ Manufacturer: Medtronic Inc. Cardiac Rhythm Managment; 7000 Central Ave Ne; Fridley MN 55432
• For Additional Information Contact: Tim Samsel; 763-505-7831
• Manufacturer 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 1,797
• Distribution: Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = DXY