BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 5772274 · Received July 6, 2016

    Report

    Report Number
    3004209178-2016-13557
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Date of Event
    June 13, 2016
    Report Date
    July 6, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSON'S DUAL. IT WAS REPORTED THAT IMPEDANCE WAS TAKEN ON THE DAY OF THIS CALL AND A LOW IMPEDANCE WAS NOTED <100 OHMS). THE IMPEDANCE WAS TAKEN AT DEFAULT SETTINGS: ALL CASE PAIRS = 1395 OHMS, ALL PAIRS WITH 0 WERE >4K, 13 = >4K, 12 =? 23 = 1395 AND THE BATTERY READ AT 2.69V. IT WAS INDICATED THAT PATIENT WAS INVOLVED IN A CAR ACCIDENT SOMETIME THIS LAST WINTER BUT REP DID NOT KNOW ANY OTHER DETAILS ABOUT THAT EVENT. REP WANTED LONGEVITY CALCULATION FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY USING 2- 3+, 1.9V, 180 HZ ,751 OHMS. C+5- , 1.9, 90, 180, 39 OHMS, 24/7 USE. REP USED 751 OHMS FOR BOTH SIDES AS CALCULATOR DID NOT GO LOW ENOUGH TO ACCOMMODATE 39 OHMS =60 MONTHS. PATIENT JUST PASSED 60 MONTHS IN FEB. NO PATIENT SYMPTOMS OR HARM WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427908 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR