FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1220392
·
Received November 4, 2008
Report
- Report Number
- 2029203-2008-00957
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- February 1, 2008
- Report Date
- October 6, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
A COMPLAINT WAS RECEIVED STATING THAT A PT WAS EXPLANTED. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LINEAR LEAD (PHASE IIIA): 50CM |