BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? CX

    MDR report key: 23168110 · Received September 29, 2025

    Report

    Report Number
    3006630150-2025-08080
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    May 1, 2025
    Report Date
    September 29, 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
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRO CODE: QRB. BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY MAY OF 2024 FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(6). BATCH: 7080109. UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12320. MODEL: SC-1232. SERIAL: (B)(6). BATCH: 580224. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES, AND THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IMAGING CONFIRMED THAT THE LEADS MIGRATED. THE PATIENT WAS ALSO EXPERIENCING IMPLANTABLE PULSE GENERATOR (IPG) CHARGING DIFFICULTIES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WELL NOT BE RETURNED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944905 INFINION? CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7079846

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention