SOLIA S 53 Adverse Event — Injury (MDR 1028232-2020-01847)
SOLIA S 53 Adverse Event — Injury (MDR 1028232-2020-01847) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SOLIA S 53; Generic name: PACING LEAD; Manufacturer: BIOTRONIK SE & CO. KG.
| Device | SOLIA S 53 |
|---|---|
| Generic name | PACING LEAD |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Report number | 1028232-2020-01847 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | AN INFECTION WAS OBSERVED FOLLOWING THE IMPLANTATION OF THIS BIOTRONIK DEVICE. THE STERILIZATION PROCESS WAS INVESTIGATED. THE VALIDATED PROCESS ASSURES THAT ALL STERILIZATION PARAMETERS, SUCH AS GAS CONCENTRATION, TEMPERATURE, HUMIDITY, ETC., ARE WITHIN ITS SPECIFIED RANGES FOR EACH DISTRIBUTED DEVICE. ADDITIONALLY AN ANALYSIS OF VALIDATED MICROBIOLOGICAL INDICATORS IS PERFORMED AFTER EVERY STERI |
| Source | openFDA MAUDE (device adverse events) |
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