LEAD MODEL 302 Adverse Event — Injury (MDR 1644487-2008-00360)
LEAD MODEL 302 Adverse Event — Injury (MDR 1644487-2008-00360) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: LEAD MODEL 302; Manufacturer: CYBERONICS, INC.; Report number: 1644487-2008-00360.
| Device | LEAD MODEL 302 |
|---|---|
| Manufacturer | CYBERONICS, INC. |
| Report number | 1644487-2008-00360 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-21 |
| Report source | Health Professional, Company representation |
| Narrative | IT WAS REPORTED THAT A PT EXPERIENCED HOARSENESS FOLLOWING EXPLANTATION OF VNS DEVICE. THE PHYSICIAN INDICATED THAT THE HOARSENESS MAY BE DUE TO A LARYNGEAL NERVE INJURY SUSTAINED DURING THE EXPLANT PROCEDURE SINCE THE ENTIRE LEAD AND ELECTRODES WERE REMOVED. THE NERVE DAMAGE HAS NOT BEEN CONFIRMED. NO MEDICAL INTERVENTION HAS BEEN TAKEN, AND THE PT IS BEING GIVEN TIME TO HEAL. A PORTION OF THE EX |
| Source | openFDA MAUDE (device adverse events) |
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