REPLY Adverse Event — Malfunction (MDR 1000165971-2020-00378)
REPLY Adverse Event — Malfunction (MDR 1000165971-2020-00378) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: REPLY; Generic name: PULSE GENERATOR, PERMANENT, IMPLANTABLE; Manufacturer: SORIN GROUP ITALIA S.R.L. - CRM FACILITY.
| Device | REPLY |
|---|---|
| Generic name | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Report number | 1000165971-2020-00378 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | A PACEMAKER REPLACEMENT PROCEDURE DUE TO NORMAL BATTERY DEPLETION WAS CONDUCTED. AFTER THE SUBJECT PACEMAKER WAS EXPLANTED, THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD CONNECTOR WITH THE SCREWDRIVER, BUT IT REPORTEDLY DID NOT WORK CORRECTLY. THE SCREWDRIVER WAS REPLACED AND ANOTHER ATTEMPT TO DISCONNECT THE LEAD WAS MADE, BUT ACCORDING TO THE PHYSICIAN, IT DIDN'T FEEL LIKE THE SCREWDRIVER WAS INSER |
| Source | openFDA MAUDE (device adverse events) |
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