BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 11832503 · Received May 17, 2021

    Report

    Report Number
    2182207-2021-00828
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3560022 LOT# SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3560022, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER REPORTED VIA MANUFACTURE REPRESENTATIVE THAT ON (B)(6) 2021, DURING THE 1ST STEP OF SACRAL NEUROMODULATION (SNM), A LEAD (REF (B)(4)) WAS IMPLANTED AND WAS CONNECTED TO THE EXTERNAL NEUROMODULATOR (REF (B)(4)) WITH A PERCUTANEOUS TEMPORARY EXTENSION (REF (B)(4)). TO ENSURE THE CONNECTOR DID NOT MIGRATE DURING THE TEST PERIOD, THE CONNECTOR WAS MADE BIGGER AS PER MEDTRONIC INSTRUCTION (= IT IS 1 OF THE 2 OPTIONS RECOMMENDED TO AVOID MIGRATION). ON (B)(6) 2021, DURING THE 2ND STEP OF SNM, THE SURGEON OPENED THE POCKET AND THE CONNECTOR WAS NO LONGER THERE, IT HAD MIGRATED. IT WAS NOTED THAT THE SURGEON PULLED ON THE LEAD SO AS TO RETRIEVE THE CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732605 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR