PROTEGO S 65 Adverse Event — Malfunction (MDR 1028232-2020-01853)
PROTEGO S 65 Adverse Event — Malfunction (MDR 1028232-2020-01853) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PROTEGO S 65; Generic name: ICD LEAD; Manufacturer: BIOTRONIK SE & CO. KG.
| Device | PROTEGO S 65 |
|---|---|
| Generic name | ICD LEAD |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Report number | 1028232-2020-01853 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | Company representation |
| Narrative | LEAD WAS EXPLANTED DUE TO NOISE, WHICH CAUSED INTERRUPTIONS IN PACING. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →