Z-0539-06

Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only

Name: Z-0539-06 Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2005-11-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2005-11-29 / Terminated

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only on 2005-11-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0539-06
Status: Terminated
Initiated: 2005-11-29
Posted: 2006-02-18
Terminated: 2007-01-04
Recalling firm: Medtronic, Inc.
Product: Sigma implantable pulse generators (IPGs) Single Chamber Pacemaker model SVVI103, for ventricular use only.
Product code: DXY Implantable Pacemaker Pulse-Generator
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 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 should the Physician and patient elect to replace the affected implanted device.
Quantity in commerce: 2,989
Distribution: Nationwide. and to OUS including: Europe, Australia, Canada, Hong Kong and Greater China, Japan, Latin America
Product codes and lots: 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 SVVI103: serial no.PJG159902H - PJG176701H, PJG432779H - PJG432895H, PJG230582M - PJG236398M, PJG677442S - PJG696014S, PJG748310S - PJG755468S, PJG747654C - PJG755171C.

Product code DXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)