BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2955157 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02515
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 28, 2013
    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
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3387-40, LOT# J0424970V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD.(B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748266, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3387-40, LOT# J0417922V, IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# J0417922V, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ORIGINAL LEAD WAS ¿BAD¿ FROM THE FACTORY. IT WAS ALSO CLARIFIED THAT THE RAGE OCCURRED WHEN THE REPLACEMENT LEAD WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT LEAD COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED AND WAS NOTED TO BE "DEFECTIVE." THE PATIENT NOTED THAT THE IN THE BEGINNING OF THE THERAPY, THE DEVICES SETTINGS WERE SET VERY LOW AND WOULD HAVE THEM INCREASED AFTER 3 WEEKS. THIS OCCURRED A TOTAL OF 3 TIMES. IT WAS REPORTED THAT THE THERAPY BENEFITS ON THE PATIENT'S LEFT SIDE WERE VERY GOOD BUT NOT SO ON THE RIGHT SIDE. IT WAS NOTED THAT THE "IMPEDANCES WERE NOT CHANGING" DURING THE VOLTAGE CHANGES ON THE DEFECTIVE LEAD. THE PATIENT WAS SETTING WAS THEN SET BACK TO THE ORIGINAL SETTINGS AND THE PATIENT EXPERIENCED "RAGE" UNTIL THEY CHANGED THE CONTACTS TO THE GOOD LEAD. IT WAS NOTED THAT THE PATIENT WAS SUSCEPTIBLE TO EMOTIONAL CHANGES DUE TO VOLTAGE CHANGES FROM THEIR THERAPY. THE PATIENT HAD GOOD TREMOR CONTROL WITH THE NEW SETTING. THE "DEFECTIVE" LEAD WAS THEN REPLACED. INFORMATION PROVIDED BY THE PATIENT'S PHYSICIAN NOTED THAT THE PATIENT'S LEAD WAS IMPLANTED A "LITTLE DEEPER" AND WAS NEAR THE AMYGDALA AS THE REASON FOR THE REPORTED "RAGE" THE PATIENT EXPERIENCED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57987 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention