FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1305340
·
Received February 4, 2009
Report
- Report Number
- 2029203-2009-00348
- Event Type
- Injury
- Date Received
- February 4, 2009
- Date of Event
- January 6, 2009
- Report Date
- January 6, 2009
- 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
- KS, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY, AND WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A REPORT OF EXPLANT WAS RECEIVED. THE PATIENT REPORTED THAT "THE IPG WAS NOT WORKING." THE PATIENT IS REPORTEDLY DOING WELL.
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 | 46 YR | Required Intervention | MODEL #: SC-2208-50| ST LINEAR LEAD |