FDA Adverse Event
Injury
Summary report: N
PRECISION
MDR report key: 1241175
·
Received November 20, 2008
Report
- Report Number
- 2029203-2008-00970
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- November 7, 2008
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORP
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED MATERIAL WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
Description of Event or Problem · 1
A REPORT WAS REC'D THAT A PT HAD AN EXPLANT DUE TO UNCOMFORTABLE STIMULATION. THE UNCOMFORTABLE STIMULATION IS STATED BY PT AS A BURNING SENSATION DOWN HER BACK WHERE THE LEADS ARE. IN ADDITION, THE BATTERY SITE IS VERY PAINFUL BECAUSE IT IS BECOMING SUPERFICIAL. THROUGH PHYSICIAN'S REQUEST, THE PT WAS ADVISED TO EXPLANT THE PRECISION SYSTEM IN ORDER TO CONDUCT AN MRI. THE PT IS REPORTEDLY DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISION | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORP | SC-1110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention | MODEL # SC-8120-70| ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES) |