PRECISION®
Report
- Report Number
- 3006630150-2014-01568
- Event Type
- Injury
- Date Received
- July 12, 2014
- Date of Event
- March 24, 2014
- Report Date
- March 24, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG AND LEADS WERE REPLACED PER PHYSICIAN'S PREFERENCE. NO DEVICE MALFUNCTION WAS SUSPECTED. THE REASON FOR LEAD REVISION WAS DUE TO INADEQUATE STIMULATION. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.
A REPORT WAS RECEIVED THAT THE IPG WOULD NOT CHARGE AFTER HAVING MULTIPLE MRIS. THE PATIENT WILL UNDERGO AN IPG AND LEAD REVISION. REASON FOR LEAD REVISION IS UNKNOWN.
A REPORT WAS RECEIVED THAT THE IPG WOULD NOT CHARGE AFTER HAVING MULTIPLE MRIS. THE PATIENT WILL UNDERGO AN IPG AND LEAD REVISION. REASON FOR LEAD REVISION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 408876 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Required Intervention |