FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2151929
·
Received July 7, 2011
Report
- Report Number
- 3006630150-2011-01038
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING HER IPG. THE PATIENT HAD LOST A SIGNIFICANT AMOUNT OF WEIGHT (NOT DEVICE RELATED) AND SINCE HAS HAD DIFFICULTIES CHARGING. THE PHYSICIAN RELOCATED THE POCKET LOCATION TO THE PATIENT'S ABDOMEN. NOTHING WAS EXPLANTED AND THE PATIENT IS 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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |