FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1392268
·
Received May 20, 2009
Report
- Report Number
- 2029203-2009-01288
- Event Type
- Injury
- Date Received
- May 20, 2009
- Date of Event
- April 27, 2009
- Report Date
- April 27, 2009
- 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
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL MEDICAL DEVICE COMPONENTS INVOLVED. MODEL: SC-2208-70, DESCRIPTION: LINEAR ST PERCUTANEOUS LEAD 70 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED BECAUSE THE MIDDLE INCISION HAD OPENED AND THE LEADS WERE EXPOSED. THE DEVICE WAS WORKING PROPERLY AND THE PATIENT WAS RECEIVING STIMULATION AND THERE WERE NO SIGNS OF INFECTION. THE PATIENT IS DOING WELL AFTER THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2208-70 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |