ILESTO 7 VR-T DX DF-1 Adverse Event — Malfunction (MDR 1028232-2020-01809)
ILESTO 7 VR-T DX DF-1 Adverse Event — Malfunction (MDR 1028232-2020-01809) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ILESTO 7 VR-T DX DF-1; Generic name: ICD; Manufacturer: BIOTRONIK SE & CO. KG.
| Device | ILESTO 7 VR-T DX DF-1 |
|---|---|
| Generic name | ICD |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Report number | 1028232-2020-01809 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE ONLY BASED ON THE RETURNED DEVICE DATA AS WELL AS THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING. IN |
| Source | openFDA MAUDE (device adverse events) |
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