FDA Adverse Event
Injury
Summary report: N
PRECISION SPECTRA®
MDR report key: 4950897
·
Received July 29, 2015
Report
- Report Number
- 3006630150-2015-01908
- Event Type
- Injury
- Date Received
- July 29, 2015
- Date of Event
- June 18, 2015
- Report Date
- June 18, 2015
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING TENDERNESS AT THE INCISIONAL SITE OVERLYING THE IPG AND DIFFICULTY CHARGING. IPG APPEARED ROTATED UPON PALPATION. RADIOGRAPHIC EVALUATION WAS DONE WHICH CONFIRMED MALPOSITION AND ROTATION OF THE IPG. THE PATIENT UNDERWENT A POCKET REVISION AND PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 493478 | PRECISION SPECTRA® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |