BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA? MRI

    MDR report key: 21810340 · Received April 9, 2025

    Report

    Report Number
    3006630150-2025-02295
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    February 18, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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-MRI, UPN: M365SC2408560, MODEL: SC-2408-56, SERIAL: (B)(6), BATCH: 7080506, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE THE SPINAL CORD STIMULATOR LEADS WERE FRAYED BY A SCALPEL. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD EXPLANT PROCEDURE. THE EXPLANTED DEVICE WILL NOT BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665520 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7080069

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention