BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 18603581 · Received January 29, 2024

    Report

    Report Number
    3006630150-2024-00332
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    July 18, 2022
    Report Date
    January 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729861638
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7070395.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IPG REPLACEMENT PROCEDURE (MFR. REPORT NO. 3006630150-2022-03904), IT WAS FOUND THAT THE PATIENTS LEFT LEAD HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545659 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7074033 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention