FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1871067
·
Received October 12, 2010
Report
- Report Number
- 3006630150-2010-01726
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- September 16, 2010
- Report Date
- September 16, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PT WILL BE EXPLANTED DUE TO SKIN EROSION AND NO LONGER NEEDING THE DEVICE. THE PT UNDERWENT A NON DEVICE RELATED PROCEDURE IN (B)(6) 2010 AND SINCE THEN THE SKIN AROUND THE IPG HAS BEEN ERODING. THE PHYSICIAN EXPLANTED THE PATIENT AND FIXED THE ERODED SKIN. THE PT IS DOING WELL FOLLOWING THE EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | ST LINEAR LEAD, 70CM 0.014 INCH STYLET PRE-LOADED| MODEL#: SC-2218-70, SERIAL #: (B)(4) |