FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1221250
·
Received November 5, 2008
Report
- Report Number
- 2029203-2008-00692
- Event Type
- Injury
- Date Received
- November 5, 2008
- Report Date
- October 6, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVAL.
Description of Event or Problem · 1
A REPORT OF A PRECISION SYS EXPLANT WAS REC'D. THE PT COULD NOT REMEMBER ANY DETAILS OF THE EXPLANT AND THE IMPLANTING PHYSICIAN DOES NOT HAVE ANY INFO REGARDING THE EXPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORP | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LINEAR LEAD (PHASE IIIA)| LINEAR LEAD (PHASE IIIA) |