FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1843785
·
Received September 22, 2010
Report
- Report Number
- 3006630150-2010-01638
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- August 24, 2010
- Report Date
- August 24, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED DUE TO INFECTION OF THE WOUND TRACK SITE. THE PATIENT IS REPORTEDLY 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 | UNK | Required Intervention | MODEL: SC-8120-50| SERIAL: (B)(4)| ARTISAN 2X8 SURGICAL LEAD- 50 CM |