SETROX S 53 Adverse Event — Injury (MDR 1028232-2020-01844)
SETROX S 53 Adverse Event — Injury (MDR 1028232-2020-01844) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SETROX S 53; Generic name: PACING LEAD; Manufacturer: BIOTRONIK SE & CO. KG.
| Device | SETROX S 53 |
|---|---|
| Generic name | PACING LEAD |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Report number | 1028232-2020-01844 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE. |
| Source | openFDA MAUDE (device adverse events) |
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