BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA MRI

    MDR report key: 20792892 · Received November 27, 2024

    Report

    Report Number
    3006630150-2024-08175
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: 7076030.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS WERE FRACTURED AND WERE CONFIRMED THROUGH AN X RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2452620 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7075819 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention