FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 2123410
·
Received June 14, 2011
Report
- Report Number
- 3006630150-2011-00905
- Event Type
- Injury
- Date Received
- June 14, 2011
- Date of Event
- May 23, 2011
- Report Date
- May 23, 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
- TN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES OBTAINING A FULL CHARGE ON HER IPG. THE PHYSICIAN ASSESSED THE PATIENT AND NOTED THAT THE IPG WAS FLIPPED. THE PHYSICIAN REVISED THE PATIENT'S POCKET SITE BY MAKING THE POCKET MORE SHALLOW. NOTHING WAS IMPLANTED OR EXPLANTED AND THE PATIENT IS REPORTEDLY DOING WELL.
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 | 69 YR | Required Intervention |