FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1232220
·
Received November 14, 2008
Report
- Report Number
- 2029203-2008-00941
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- June 1, 2007
- Report Date
- October 15, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO SKIN EROSION AT THE POCKET SITE. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ARTISAN 2X8 PADDLE LEAD:| MODEL # SC-8116-50 |