FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1980316
·
Received February 2, 2011
Report
- Report Number
- 3006630150-2011-00142
- Event Type
- Injury
- Date Received
- February 2, 2011
- Date of Event
- January 11, 2011
- Report Date
- January 11, 2011
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED IPG PASSED, VISUAL, ELECTRICAL AND PERFORMANCE TESTS. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS.
Description of Event or Problem · 1
A REPORT WAS REC'D THAT THE PT UNDERWENT A POCKET REVISION PROCEDURE DUE TO DISCOMFORT AT THE POCKET SITE. THE POCKET SITE WAS RELOCATED AND THE PHYSICIAN ELECTED TO REPLACE THE IPG SINCE THE PT HAD NOT CHARGED HIS IPG. THERE WAS NOTHING WRONG WITH THE DEVICE.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE DUE TO DISCOMFORT AT THE POCKET SITE. THE POCKET SITE WAS RELOCATED AND THE PHYISICAN ELECTED TO REPLACE THE IPG SINCE THE PATIENT HAD NOT CHARGED HIS IPG. THERE WAS NOTHING WRONG WITH THE DEVICE.
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 | 47 YR | Required Intervention |