TILDA R 53 US Adverse Event — Malfunction (MDR 1028232-2020-01865)
TILDA R 53 US Adverse Event — Malfunction (MDR 1028232-2020-01865) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TILDA R 53 US; Generic name: LEAD; Manufacturer: BIOTRONIK SE & CO. KG.
| Device | TILDA R 53 US |
|---|---|
| Generic name | LEAD |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Report number | 1028232-2020-01865 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | IT WAS REPORTED IN REGARD TO THIS RV LEAD THAT: THIS LEAD WAS FRACTURED DUE TO SUBCLAVIAN CRUSH. THE LEAD WAS EXPLANTED. |
| Source | openFDA MAUDE (device adverse events) |
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