LEAD MODEL UNKNOWN Adverse Event — Malfunction (MDR 1644487-2020-00631)
LEAD MODEL UNKNOWN Adverse Event — Malfunction (MDR 1644487-2020-00631) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEAD MODEL UNKNOWN; Generic name: LEAD; Manufacturer: LIVANOVA USA, INC..
| Device | LEAD MODEL UNKNOWN |
|---|---|
| Generic name | LEAD |
| Manufacturer | LIVANOVA USA, INC. |
| Report number | 1644487-2020-00631 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON THAT THE CAUSE OF THE LEAD FRACTURE WAS DUE TO SCAR TISSUE BUILT UP OVER THE YEARS. NO ADDITIONAL RELATIVE INFORMATION HAS BEEN RECEIVED TO DATE. |
| Source | openFDA MAUDE (device adverse events) |
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