FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2003966
·
Received March 1, 2011
Report
- Report Number
- 3006630150-2011-00282
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED THAT DURING REVISION THE PHYSICIAN ROTATED THE IPG BACK TO THE CORRECT POSITION. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING HIS IPG. X-RAYS CONFIRMED THE IPG HAD FLIPPED IN THE POCKET. THE PHYSICIAN WILL PERFORM A POCKET REVISION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING HIS IPG. X-RAYS CONFIRMED THE IPG HAD FLIPPED IN THE POCKET. THE PHYSICIAN WILL PERFORM A POCKET REVISION.
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 | Required Intervention |