PRECISION®
Report
- Report Number
- 3006630150-2011-00626
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT THE POCKET REVISION AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE POCKET REVISION WAS PUT ON HOLD AS THE PATIENT WAS GIVEN LIDODERM PATCHES TO TEST FOR THREE WEEKS. THE NEXT COURSE OF ACTION REGARDING THE REVISION WILL BE MADE AFTER THE THREE WEEK TRIAL OF THE PAIN PATCHES.
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO PAIN AT THE POCKET SITE CAUSED BY THE IPG MIGRATING TOWARDS THE SKIN.
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO PAIN AT THE POCKET SITE CAUSED BY THE IPG MIGRATING TOWARDS THE SKIN.
A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO A POCKET REVISION DUE TO PAIN AT THE POCKET SITE CAUSED BY THE IPG MIGRATING TOWARDS THE SKIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |