FDA Adverse Event
Injury
Summary report: N
LINEAR? ST
MDR report key: 22668551
·
Received July 30, 2025
Report
- Report Number
- 3006630150-2025-05983
- Event Type
- Injury
- Date Received
- July 30, 2025
- Date of Event
- June 3, 2025
- Report Date
- July 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7161443, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DESPITE OPTIMIZING THE PROGRAM. THE PHYSICIAN EVALUATED THE SPINAL CORD STIMULATOR (SCS) DEVICE UNDER FLUOROSCOPY AND SHOWED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE PHYSICIAN PULLED THE LEADS DOWN TO AN APPROPRIATE LEVEL TO COVER THE PAIN AREAS. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE LEADS REMAIN IMPLANTED AND IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549912 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7150797 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Required Intervention |