FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3143590
·
Received June 3, 2013
Report
- Report Number
- 3006630150-2013-01161
- Event Type
- Injury
- Date Received
- June 3, 2013
- Date of Event
- April 15, 2013
- Report Date
- May 9, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT POCKET PAIN WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN INJECTION AND WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243735 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1132 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |