FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2007230
·
Received March 4, 2011
Report
- Report Number
- 3006630150-2011-00264
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 24, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HER IPG. THE BSN FIELD CLINICAL ENGINEER (FCE) MET WITH THE PATIENT AND NOTED THE IPG WAS SLIGHTLY TILTED AND VERY LOW IN THE BUTTOCKS REGION. THE FCE WAS ABLE TO CHARGE THE IPG WHEN THE CHARGER WAS PROPERLY ALIGNED. THE PHYSICIAN REVISED THE PATIENT'S POCKET AND ELECTED TO REPLACE THE IPG. THE PATIENT 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-1110-02 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |