BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 25225536 · Received May 19, 2026

    Report

    Report Number
    3006630150-2026-03318
    Event Type
    Injury
    Date Received
    May 19, 2026
    Date of Event
    July 9, 2025
    Report Date
    May 19, 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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE: QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT(S) INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7082140 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A NON DEVICE RELATED FALL, AFTER WHICH THE STIMULATION WAS INADEQUATE IN PROVIDING AS MUCH RELIEF AS PREVIOUSLY GETTING. THE SPINAL CORD STIMULATION (SCS) LEADS DISPLAYED HIGH IMPEDANCES. RE-PROGRAMMING WAS PERFORMED AND THE PATIENT DID RECEIVE REASONABLE COVERAGE. HOWEVER, THE PATIENT THEN EXPERIENCED LOSS OF STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPLACED. THERE WERE NO REPORTED COMPLICATIONS POST OPERATIVELY, AND THE PATIENT WAS NOTED TO HAVE RECOVERED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102471 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7081996 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1