DEXTRUS 60 MODEL 4137 US 644137-102 Adverse Event — Malfunction (MDR 1028232-2020-01860)
DEXTRUS 60 MODEL 4137 US 644137-102 Adverse Event — Malfunction (MDR 1028232-2020-01860) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DEXTRUS 60 MODEL 4137 US 644137-102; Generic name: PACING LEAD; Manufacturer: BIOTRONIK SE & CO. KG.
| Device | DEXTRUS 60 MODEL 4137 US 644137-102 |
|---|---|
| Generic name | PACING LEAD |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Report number | 1028232-2020-01860 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THE LEAD IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN BASED ON AVAILABLE INFORMATION 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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