FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 2000966
·
Received February 18, 2011
Report
- Report Number
- 3006630150-2011-00221
- Event Type
- Injury
- Date Received
- February 18, 2011
- Date of Event
- January 25, 2011
- Report Date
- January 25, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO POCKET PAIN. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS REC'D THAT THE PT UNDERWENT A POCKET REVISION DUE TO POCKET PAIN. THE PT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |