FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 10958205
·
Received December 7, 2020
Report
- Report Number
- 3006630150-2020-06039
- Event Type
- Injury
- Date Received
- December 7, 2020
- Date of Event
- November 14, 2020
- Report Date
- December 7, 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
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7070457. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 5167251.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS LEAD AT THE OCCIPITAL AREA WAS PROTRUDING THROUGH THE SKIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE MOVED SO IT WAS NOT PUSHING AGAINST THE SKIN. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1424291 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5154894 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |