VERCISE CARTESIA Adverse Event — Injury (MDR 3006630150-2020-01916)
VERCISE CARTESIA Adverse Event — Injury (MDR 3006630150-2020-01916) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VERCISE CARTESIA; Generic name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS; Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION.
| Device | VERCISE CARTESIA |
|---|---|
| Generic name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS |
| Manufacturer | BOSTON SCIENTIFIC NEUROMODULATION |
| Report number | 3006630150-2020-01916 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | IT WAS REPORTED THAT AT SOME TIME IN 2020, POST IMPLANT, THE PATIENT DEVELOPED WOUND HEALING DISTURBANCE WHICH WAS MODERATE IN SEVERITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SECRETION AND SLOUGHING IN THE AREA OF THE LEFT ANTERIOR SCAR. THE PATIENT UNDERWENT A REVISION OF THE LEFT BRAIN LEAD AND RECEIVED PROPHYLACTIC TREATMENT WITH IV ANTIBIOTICS FOR 3 DAYS. THE PATIENT DATE OF BIRTH IS 1 |
| Source | openFDA MAUDE (device adverse events) |
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