FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 11078892
·
Received December 28, 2020
Report
- Report Number
- 3006630150-2020-06439
- Event Type
- Injury
- Date Received
- December 28, 2020
- Date of Event
- November 2, 2020
- Report Date
- December 28, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5121227/5170635.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO LEAD MIGRATION CONFIRMED VIA X-RAY. THE PATIENT WAS REPROGRAMMED, HOWEVER, UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN A LINEAR LEAD WAS ADDED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NOTHING WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1542788 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5159233 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |