BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 22733846 · Received August 6, 2025

    Report

    Report Number
    3006630150-2025-06213
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    April 7, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: QRB. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7081182. UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 30731192. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS SPINAL CORD STIMULATOR LEAD HAD HIGH IMPEDANCES AND WAS NOTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528618 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-70 7080471

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention