BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA? MRI

    MDR report key: 21384977 · Received February 14, 2025

    Report

    Report Number
    3006630150-2025-00732
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 2, 2024
    Report Date
    April 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 7072036.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEAD WAS FRACTURED, CAUSING HIGH IMPEDANCE. LEAD FRACTURE WAS NOT CONFIRMED THROUGH IMAGING. NO FURTHER INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) LEAD WAS FRACTURED CAUSING HIGH IMPEDANCE. HIGH IMPEDANCE WERE CONFIRM THROUGH CP (CLINICIAN'S PROGRAMMER). ADDITIONAL INFORMATION WAS RECEIVED THAT UNDERWENT AN EXPLANT PROCEDURE AND EXPLANTED DEVICES WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414822 AVISTA? MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2408-56 7071792

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention