PRECISION®
Report
- Report Number
- 3006630150-2013-00874
- Event Type
- Injury
- Date Received
- May 3, 2013
- Report Date
- April 12, 2013
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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.
DATE OF EVENT: (B)(6) 2012. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL / LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING ITCHINESS ALL OVER HER BODY MOSTLY ON HER FACE AND NECK. A VARIETY OF TREATMENT WAS ADMINISTERED TO THE PATIENT WITH NO SUCCESS. THE PHYSICIAN BELIEVED IT WAS DEVICE RELATED AS THE PATIENT FELT THE ITCHING WHEN THE DEVICE WAS ON. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL AFTER.
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING ITCHINESS ALL OVER HER BODY MOSTLY ON HER FACE AND NECK. A VARIETY OF TREATMENT WAS ADMINISTERED TO THE PATIENT WITH NO SUCCESS. THE PHYSICIAN BELIEVED IT WAS DEVICE RELATED AS THE PATIENT FELT THE ITCHING WHEN THE DEVICE WAS ON. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL AFTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195326 | PRECISION® | SPINAL CORD STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1110-02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |