BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3212830 · Received July 9, 2013

    Report

    Report Number
    3007566237-2013-02283
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION: PRODUCT ID NEU_UNKNOWN_LEAD: PRODUCT TYPE LEAD; PRODUCT ID 7428, SERIAL# UNKNOWN: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN: PRODUCT TYPE LEAD; PRODUCT ID 7428, SERIAL# UNKNOWN: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICES HAD SHORTS AND OPENS DUE TO BROKEN WIRES. IT WAS STATED THAT THE PREVIOUS MENTIONED EVENT WAS ALREADY REPORTED AND THE HEALTHCARE PROVIDER (HCP) WAS CALLING FOR LONGEVITY MEASUREMENTS IN THE PATIENT¿S 4 DEVICES. THERE WAS NO PREVIOUS REPORT FOUND. THE LONGEVITY CALCULATION FOR THE RIGHT IMPLANT (4.0 V, 210 MICROSECONDS, 60 HERTZ, THERAPY IMPEDANCE 522 OHMS) WAS 47 MONTHS AND THE LEFT IMPLANT (1.8 V, 360 MICROSECONDS, 60 HERTZ, THERAPY IMPEDANCE 361 OHMS) WAS 70 MONTHS. IT WAS NOTED THAT THE PATIENT ALSO HAD TWO OTHER DEVICES THAT HAD NO REPORTED PROBLEM (ONE HAD A LONGEVITY ESTIMATE FOR 79 MONTHS AND THE OTHER HAD AN ESTIMATED EARLY REPLACEMENT INDICATOR AT 5 YEARS, END OF SERVICE AT 5.3 YEARS). PLEASE REFER TO MFG. REPORT # 3007566237-2013-02282, AS THE PATIENT HAD TWO UNKNOWN DEVICES. THE PREVIOUS REPORT COULD NOT BE FOUND. THE PATIENT AND DEVICE INFORMATION WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314426 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1