FDA Adverse Event
Injury
Summary report: N
LINEAR? ST
MDR report key: 24653574
·
Received March 20, 2026
Report
- Report Number
- 3006630150-2026-01667
- Event Type
- Injury
- Date Received
- March 20, 2026
- Date of Event
- November 17, 2025
- Report Date
- May 12, 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
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7172655, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM, UNIQUE IDENTIFIER (UDI)#: ((B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED LOSS OF STIMULATION DUE TO THE SPINAL CORD STIMULATOR (SCS) LEADS HAD MIGRATED. X-RAY IMAGING WAS PERFORMED TO CONFIRM DEVICE MIGRATION. THE PATIENT UNDERWENT A SCS LEAD REPLACEMENT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259898 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7163778 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |