FDA Adverse Event
Injury
Summary report: N
LINEAR? ST
MDR report key: 24513406
·
Received March 4, 2026
Report
- Report Number
- 3006630150-2026-01258
- Event Type
- Injury
- Date Received
- March 4, 2026
- Date of Event
- June 5, 2025
- Report Date
- May 11, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7160136 UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THAT LEAD MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE. PRODUCT WAS DISPOSED OF AND NOT SENT BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590348 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7162416 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male | Required Intervention |