FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 12620630
·
Received October 12, 2021
Report
- Report Number
- 3006630150-2021-05731
- Event Type
- Injury
- Date Received
- October 12, 2021
- Date of Event
- July 9, 2021
- Report Date
- October 12, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- 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: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7073078.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION. AN X-RAY WAS DONE AND CONFIRMED LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEADS WERE RETAINED BY THE FACILITY. THE PATIENT IS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1514082 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | 5056968 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |