FDA Adverse Event
Injury
Summary report: N
PRECISION®
MDR report key: 5226804
·
Received November 16, 2015
Report
- Report Number
- 3006630150-2015-02931
- Event Type
- Injury
- Date Received
- November 16, 2015
- Date of Event
- July 20, 2015
- Report Date
- July 20, 2015
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM. THERE WAS NO COMPLAINT TOWARD THE DEVICE FUNCTIONALITY. SC-1110/243013: THE DEVICE PASSED THE FUNCTIONAL TEST AND REVEALED NO ANOMALIES. SC-2218-70-70/547950, (B)(4): THE LEAD WAS CUT DURING THE EXPLANT PROCEDURE. X-RAY INSPECTION FOUND THAT THE CABLES WERE ALL INTACT.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT WHEN THE PATIENT TURNED ON HER STIMULATION, HER COMPLEX REGIONAL PAIN SYNDROME (CRPS) FLARED UP. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756840 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |