FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 3130922
·
Received May 24, 2013
Report
- Report Number
- 3006630150-2013-01061
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 1, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL, ELECTRICAL AND PERFORMANCE TESTS PERFORMED. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG MIGRATED AND WAS TILTED HORIZONTALLY WHICH WAS CONFIRMED THROUGH FLUOROSCOPY. THE PATIENT WAS THEN EXPERIENCING CHARGING DIFFICULTIES. THE PATIENT UNDERWENT BATTERY REPLACEMENT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT¿S IPG MIGRATED AND WAS TILTED HORIZONTALLY WHICH WAS CONFIRMED THROUGH FLUOROSCOPY. THE PATIENT WAS THEN EXPERIENCING CHARGING DIFFICULTIES. THE PATIENT UNDERWENT BATTERY REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232290 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |