FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1943674
·
Received December 21, 2010
Report
- Report Number
- 3006630150-2010-02222
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- November 29, 2010
- Report Date
- November 29, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR ANALYSIS AS THEY WERE KEPT BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PT'S PRECISION SYS WAS EXPLANTED, BECAUSE THE PT HAD CONTRACTED MENINGITIS. THE DEVICES WERE WORKING PROPERLY PRIOR TO BEING EXPLANTED. THE PT IS REPORTEDLY DOING WELL FOLLOWING THE EXPLANT PROCEDURE.
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 | 80 YR | Required Intervention | (B)(4)| MODEL# SC-2218-50| (B)(4)| ST LINER LEAD, 50CM WITH PRE-LOADED 0.014" STYLET: |