MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35 CM Adverse Event — Malfunction (MDR 2183787-2020-00038)
MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35 CM Adverse Event — Malfunction (MDR 2183787-2020-00038) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35 CM; Generic name: BIPOLAR EPICARDIAL LEAD; Manufacturer: GREATBATCH MEDICAL.
| Device | MYOPORE SUTURELESS MYOCARDIAL PACING LEAD, 35 CM |
|---|---|
| Generic name | BIPOLAR EPICARDIAL LEAD |
| Manufacturer | GREATBATCH MEDICAL |
| Report number | 2183787-2020-00038 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR |
| Narrative | IT WAS REPORTED THAT A PATIENT WAS OPERATED FOR ASD DURING WHICH SHE HAD GONE INTO CHB , SO SHE HAD BEEN IMPLANTED WITH PACEMAKER SN (B)(4) WITH AN EPICARDIAL LEAD. INITIALLY THRESHOLD WAS GOOD WHICH THEN STARTED INCREASING GRADUALLY WITH EVERY CHECKUP, SO OUTPUT WAS INCREASED. THE RECENT FOLLOW-UP OF THE PATIENT THE PACEMAKER HAS REACHED ERT. |
| Source | openFDA MAUDE (device adverse events) |
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