FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 11269549
·
Received February 2, 2021
Report
- Report Number
- 3006630150-2021-00207
- Event Type
- Injury
- Date Received
- February 2, 2021
- Date of Event
- January 13, 2021
- Report Date
- February 2, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 5132972.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT WAS NO LONGER RECEIVING BENEFIT FROM HER LEADS. THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE TWO OF HER LEADS WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165347 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | 5108105 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |