FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1970303
·
Received January 14, 2011
Report
- Report Number
- 3006630150-2011-00046
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- December 23, 2010
- Report Date
- December 23, 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED IPG PASSED VISUAL AND PERFORMANCE TESTS DONE. THE DEVICE WORKS ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN RELOCATED THE PATIENT'S POCKET SITE AND REPLACED THE IPG. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT IS EXPERIENCING DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN RELOCATED THE PATIENT'S POCKET SITE AND REPLACED THE IPG. THE PATIENT IS DOING WELL FOLLOWING THE REVISION.
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 | 65 YR | Required Intervention |