BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4760204 · Received May 8, 2015

    Report

    Report Number
    3004209178-2015-08771
    Event Type
    Injury
    Date Received
    May 8, 2015
    Report Date
    April 17, 2015
    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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V101646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V108523, IMPLANTED: (B)(6) 2008,PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING SHOCKS AND THERE WAS A QUESTION OF SOME MALFUNCTION OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WHEN THE PATIENT MET WITH THEIR HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2010. THE PATIENT¿S RIGHT SIDE WAS PROGRAMMED TO 5-, 6-, 7+ AT 4V, 90 USEC, AND 185 HZ AND THEIR LEFT SIDE WAS PROGRAMMED TO 1-, 3+ AT 3.8V, 90 USEC, AND 185 HZ. THERE WAS A QUESTION OF AN INTERMITTENT CIRCUIT PROBLEM. THE HCP FELT THE INS SHOULD BE REPLACED. AFTER THE INS WAS REPLACED, IMPEDANCES WERE ALL MEASURED TO BE NORMAL AND THE INS WAS PROGRAMMED USING THE PATIENT¿S OLD SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304445 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention