Medtronic, Inc.DTBClass III

Permanent Pacemaker Electrode

Medtronic, Inc.'s record for this product code

MDR events8,987All time

Recalls2All time

510(k) clearances0All time

Recent MDR events

8,987 adverse event reports on file

Recalls

2 recall events for this product code

TerminatedOct 5, 2015
Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
View FDA record ↗
TerminatedMar 23, 2010
Medtronic has identified a packaging issue for a subset of Epicardial Leads Model 5071. They determined that specific package seals could be compromised. Medtronic is not aware of any patient injury due to this packaging issue and their evaluation indicated the risk of patient injury is remote. However, a compromised package seal could potentially affect product sterility.
View FDA record ↗

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for Medtronic, Inc. under this product code.