BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2802842 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09471
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3550-09 LOT# N279806 IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N250614, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N279806, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-09 LOT# N250614, IMPLANTED: 2011 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3391S-40 LOT# V159340, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3391S-40 LOT# V159340, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4). ANALYSIS OF THE DEVICE, SERIAL # (B)(4), FOUND THE DEVICE FUNCTIONALLY OKAY WITH INSIGNIFICANT ANOMALIES / NO SIGNIFICANT ANOMALIES. ANALYSIS OF THE ACCESSORY KIT PLUG AND CAP, LOT # N279806, FOUND NO ANOMALY. ANALYSIS OF LEAD 1, LOT # N250614, FOUND THE LEAD BODY WAS STRETCHED WITH NO SIGNIFICANT ANOMALY. ANALYSIS OF THE EXTENSION, SERIAL # (B)(4), FOUND THE EXTENSION BODY CUT THROUGH AND SEGMENTED WITH NO SIGNIFICANT ANOMALY. ANALYSIS OF LEAD 2, LOT # N250614, FOUND THE PROXIMAL END CONDUCTOR BROKEN (OVERSTRESSED/DAMAGED) WITH NO SIGNIFICANT ANOMALY. ANALYSIS OF THE ACCESSORY KIT PLUG AND CAP, LOT # N250614, FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION, SERIAL # (B)(4), FOUND THE EXTENSION BODY OUTER INSULATION HAD A BREACHED DEPRESSION. ANALYSIS OF THE DEVICE, SERIAL # (B)(4), FOUND THAT THE DEVICE BATTERY WAS NOT IN NEW CONDITION WITH NO SIGNIFICANT ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A CLINICAL TRIAL AND HAD THE SYSTEM EXPLANTED, BECAUSE, THE PATIENT AND THE PSYCHIATRIST AGREED THAT THE DEVICE WAS NOT EFFECTIVE. IT WAS NOTED THAT DIAGNOSTICS WERE NOT COMPLETED BEFORE EXPLANT AND NO MALFUNCTIONS WERE DETERMINED. THE PATIENT REMAINED HOSPITALIZED FOR GREATER THAN 24 HOURS AFTER EXPLANT, AS PER THE STANDARD OF CARE, AND RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention