FDA Adverse Event
Malfunction
Summary report: N
LINEAR? ST
MDR report key: 24562884
·
Received March 10, 2026
Report
- Report Number
- 3006630150-2026-01397
- Event Type
- Malfunction
- Date Received
- March 10, 2026
- Date of Event
- February 12, 2026
- Report Date
- March 10, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7150747 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM UNIQUE IDENTIFIER (UDI) (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING LEAD SYNC AND IMPEDANCE CHECK, IT WAS FOUND THAT THE PATIENTS LEADS HAD SEVERAL HIGH IMPEDANCES. IT WAS NOTED THAT THE IMPEDANCES AND MAGNETIC RESONANCE IMAGING (MRI) ERROR APPEARED TO BE RELATED TO LEAD FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 626005 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7150609 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Male |