FDA Adverse Event
Injury
Summary report: N
LINEAR? ST
MDR report key: 24321506
·
Received February 12, 2026
Report
- Report Number
- 3006630150-2026-00844
- Event Type
- Injury
- Date Received
- February 12, 2026
- Date of Event
- October 17, 2025
- Report Date
- February 12, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL: (B)(6) BATCH: 7102180 UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING WAS TAKEN AND SPINAL CORD STIMULATION (SCS) LEAD MIGRATION WAS CONFIRMED. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383734 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-70 | 7102447 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Required Intervention |