BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 24345679 · Received February 16, 2026

    Report

    Report Number
    3006630150-2026-00916
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    June 1, 2025
    Report Date
    May 6, 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
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN JUNE 2025 PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7083451. UPN: M365SC2317700. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI. MODEL: SC-1232. SERIAL: (B)(6). BATCH: 574508. UPN: M365SC12320. UDI: (B)(4). BLOCK D2B: LGW, QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO THE SPINAL CORD STIMULATOR (SCS) LEAD HAD MULTIPLE CONTACTS THAT HAD IMPEDANCES. THE PATIENT UNDERWENT A SCS REPLACEMENT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384715 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7083911 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention