BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1062203 · Received June 6, 2008

    Report

    Report Number
    3004209178-2008-03049_
    Event Type
    Injury
    Date Received
    June 6, 2008
    Date of Event
    March 1, 2007
    Report Date
    May 8, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    p960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT, THE DEVICE WAS PROGRAMMED TO 6 VOLTS CONTINUOUS FOR A YEAR AND HALF. THE PT EXPERIENCED DECREASED SPEECH AND EYE APRAXIA. ONE MO AFTER THE IMPLANT, THE PT HAD A MEDICATION INCREASE, AN INCREASE IN OFF TIME, AND AN INCREASE IN VIOLENT TREMOR ON BOTH SIDES. THE IMPLANTABLE PULSE GENERATOR WAS PUSHING ON HER RIB CAGE, CAUSING GREAT PAIN. A MO LATER THE PT HAD A COMPLETE RETURN OF SYMPTOMS. THE PT CONFIRMED THAT THE DEVICE WAS ON. THE PT HAD INCREASED THE AMPLITUDE TO THE HIGHEST LEVEL. A COMPUTERIZED TOMOGRAPHY SCAN WAS COMPLETED AND IT WAS REPORTED THAT THE LEADS WERE VERY DEEP. THE BATTERIES WERE DEPLETED DUE TO THE HIGH VOLTAGE. THE PT WENT FOR A SECOND OPINION, HAD A MAGNETIC RESONANCE IMAGING, AND WAS TOLD THE DEVICE WAS NOT PROGRAMMED. THE IMPLANTABLE PULSE GENERATOR WAS REPLACED. PLEASE REFERENCE MFG 3004209178-2008-00739.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MHY MEDTRONIC PUERTO RICO OPERATIONS CO 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 3387 LOT# J0555533V| IMPLANTED| IMPLANTED| PROGRAMMER TYPE MODEL 7436 LOT# NFU009920P| IMPLANTED| EXTENSION MODEL 7482 LOT# NHU071882V| LEAD MODEL 3887 LOT# J0555533V| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU071883V| EXPLANTED