SPECTRA WAVEWRITER Adverse Event — Injury (MDR 3006630150-2020-01905)
SPECTRA WAVEWRITER Adverse Event — Injury (MDR 3006630150-2020-01905) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPECTRA WAVEWRITER; Generic name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF; Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION.
| Device | SPECTRA WAVEWRITER |
|---|---|
| Generic name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Manufacturer | BOSTON SCIENTIFIC NEUROMODULATION |
| Report number | 3006630150-2020-01905 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | A REPORT WAS RECEIVED THAT THE PATIENT HAD A NON-DEVICE RELATED FALL WHICH RESULTED TO A SWELLING AROUND THE IPG SITE. IT WAS ALSO REPORTED THAT THE PATIENT DID LAND ON THE IMPLANT SITE AND THE PATIENT WAS HOSPITALIZED. |
| Source | openFDA MAUDE (device adverse events) |
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