FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3233157
·
Received July 18, 2013
Report
- Report Number
- 3006630150-2013-01499
- Event Type
- Injury
- Date Received
- July 18, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IPG DUE TO THE BATTERY BEING PLACED TOO DEEP. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE OLD IPG WAS REPLACED. THERE WAS NO SUSPECTED DEVICE MALFUNCTION WITH THE OLD IPG. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333641 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |