Recall Z-0536-06 ยท DXY Implantable Pacemaker Pulse-Generator
Medtronic Inc. Cardiac Rhythm Managment
Sigma implantable pulse generators (IPGs) Dual Chamber Atrial Sensing, Ventricular Sensing and Pacing Pacemaker. Atrial Bipolar sensing connector, ventricular Bipolar connector, model SVDD303.
| Date | Feb 18, 2006 (initiated Nov 29, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root 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 shou |
| Quantity | 1,797 |
| Distribution | Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.