BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION CX

    MDR report key: 20472807 · Received October 17, 2024

    Report

    Report Number
    3006630150-2024-07058
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    August 22, 2024
    Report Date
    October 17, 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
    FL, 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: 7080962.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO HIGH IMPEDANCES ON THE SPINAL CORD STIMULATION (SCS) LEADS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE OLD LEADS WERE REPLACED WITH A MAGNETIC RESONANCE IMAGING (MRI) CAPABLE ONE. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035019 INFINION CX STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2317-70 7080929 08714729861638

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention