FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1132654
·
Received August 22, 2008
Report
- Report Number
- 2029203-2008-00545
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- May 29, 2007
- Report Date
- July 24, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODUATLION 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
ALL SUSPECTED DEVICES WERE EXPLANTED AND WILL NOT BE RETURNED FOR EVALUATION, AS THEY WERE NOT RELEASED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A PATIENT REPORTED INADEQUATE PAIN COVERAGE. THE SCS SYSTEM WAS EXPLANTED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODUATLION CORPORATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |