BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVISTA MRI

    MDR report key: 19274501 · Received May 8, 2024

    Report

    Report Number
    3006630150-2024-02982
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    September 8, 2022
    Report Date
    May 8, 2024
    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
    JA
    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-LOT (B)(6) BATCH 5172274.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE SPINAL CORD STIMULATION (SCS) LEADS WERE EXPLANTED AND REPLACED. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519410 AVISTA MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2408-56 5141695 08714729904816

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention