Permanent Pacemaker Electrode
Greatbatch Medical's record for this product code
Recent MDR events
1,486 adverse event reports on file
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJul 8, 2026Malfunction2183787-2026-00043
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJul 7, 2026Injury2183787-2026-00048
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJul 2, 2026Malfunction2183787-2026-00049
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJul 2, 2026Malfunction2183787-2026-00046
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJul 2, 2026Malfunction2183787-2026-00047
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJun 29, 2026Malfunction2183787-2026-00042
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJun 29, 2026Injury2183787-2026-00044
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJun 29, 2026Injury2183787-2026-00045
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJun 26, 2026Injury2183787-2026-00041
- MYOPORE® SUTURELESS MYOCARDIAL PACING LEADJun 26, 2026Injury2183787-2026-00040
Recalls
3 recall events for this product code
- TerminatedNov 2, 2010
The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode.
View FDA record ↗ - TerminatedDec 29, 2009
The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
View FDA record ↗ - TerminatedDec 29, 2009
The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Greatbatch Medical under this product code.