BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 21108405 · Received January 8, 2025

    Report

    Report Number
    3006630150-2025-00009
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    November 14, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729861614
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: (B)(4) MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: 7070815

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN A MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE DEVICE WAS IMPLANTED. THE EXPLANTED LEADS WERE NOT RETURNED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387270 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2317-50 7070631 08714729861614

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention