FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1892665
·
Received October 28, 2010
Report
- Report Number
- 3006630150-2010-01841
- Event Type
- Injury
- Date Received
- October 28, 2010
- Date of Event
- October 5, 2010
- Report Date
- October 5, 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
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT A PATIENT HAD AN INFECTION. THE PATIENT'S SYMPTOMS WERE REDNESS AND SWELLING. THE PHYSICIAN ASSESSED THE PATIENT'S WOUND AND PRESCRIBED THE PATIENT ORAL AND TOPICAL ANTIBIOTICS. IN ADDITION, THE PHYSICIAN DID NOT BELIEVE THE INFECTION TO BE DEVICE RELATED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING TREATMENT.
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 | 36 YR | Required Intervention |