FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1812633
·
Received August 17, 2010
Report
- Report Number
- 3006630150-2010-01384
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- June 23, 2010
- Report Date
- July 20, 2010
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING DIFFICULTIES CHARGING THE IPG. IT WAS DETERMINED THAT THE POCKET IS TOO DEEP. THE PHYSICIAN NOTICED FLUID ON THE POCKET INCISION AND SWELLING. THE PHYSICIAN BELIEVES THAT IT IS PROCEDURE-RELATED, AS THE PATIENT WAS RECENTLY IMPLANTED. A POCKET REVISION HAS BEEN RECOMMENDED, BUT NO FURTHER ACTION IS BEING TAKEN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |