SOLIA S 45 Adverse Event — Malfunction (MDR 1028232-2020-01858)
SOLIA S 45 Adverse Event — Malfunction (MDR 1028232-2020-01858) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SOLIA S 45; Generic name: PACING LEAD; Manufacturer: BIOTRONIK SE & CO. KG.
| Device | SOLIA S 45 |
|---|---|
| Generic name | PACING LEAD |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Report number | 1028232-2020-01858 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE ANALYSIS IS THUS BASED ON THE INSPECTION OF THE MANUFACTURING DOCUMENTS OF THE DEVICE AS WELL AS ON THE PROVIDED DATA. IN THE RECORDED PERIOD BETWEEN (B)(6) 2019 AND (B)(6) 2020, THE RIGHT VENTRICULAR PACING IMPEDANCE WAS INITIALLY RECORDED AT 400 OMHS, BEFORE THE RECORDING STO |
| Source | openFDA MAUDE (device adverse events) |
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