BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVISTA MRI

    MDR report key: 15365268 · Received September 6, 2022

    Report

    Report Number
    3006630150-2022-04560
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    October 29, 2021
    Report Date
    January 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729904816
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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)(4). BATCH: 20185056.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND LOSS OF STIMULATION DUE TO HIGH IMPEDANCES DESPITE REPROGRAMMING. AN X RAY WAS TAKEN AND THE LEAD LOOKED AS IF IT WAS FRACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND LOSS OF STIMULATION DUE TO HIGH IMPEDANCES DESPITE REPROGRAMMING. AN X RAY WAS TAKEN, AND THE LEAD LOOKED AS IF IT WAS FRACTURED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN A PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEADS WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2831211 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 20080410 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention