FDA Adverse Event
Malfunction
Summary report: N
INFINION? CX
MDR report key: 24445865
·
Received February 25, 2026
Report
- Report Number
- 3006630150-2026-01107
- Event Type
- Malfunction
- Date Received
- February 25, 2026
- Date of Event
- January 29, 2026
- Report Date
- February 25, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- 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. BLOCK D2B: PRO CODE (PRODUCT CODE): QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317700; MODEL: SC-2317-70; SERIAL: (B)(6); BATCH: 7080657; UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEAD WAS FRACTURED. HIGH IMPEDANCES AND INADEQUATE STIMULATION WERE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508253 | INFINION? CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-70 | 7078421 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male | Required Intervention |