BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3050381 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05863
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 20, 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V238061, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. THE PATIENT WAS REPORTEDLY RECEIVING INTERMITTENT SHOCK SENSATIONS AT THE RIGHT BURR HOLE CAP SITE. IMPEDANCES WERE REPORTEDLY CHECKED IN MULTIPLE POSITIONS AND PRESSURE WAS PUT ON THE CAP. IT WAS NOTED THAT THE DEVICE WAS TURNED OFF AND COULD NOT ELICIT THE SENSATION. IT WAS NOTED THAT THIS WAS "CLEARLY JUST WHEN THE STIMULATION IS ON". THE PATIENT WAS REPORTEDLY SENT FOR X-RAYS. IMPEDANCES AND SETTINGS WERE NOTED AS C-0 1094, C-1 961, C-2 961, C-3 924, 0-1 1094, 0-2 1413, 0-3 1467, 1-2 1008, 1-3 1210, 2-3 946. THERAPY 875 OHMS. SETTINGS: C-1, 3.5V, 90PW, 135 RATE. IT WAS NOTED THAT THE PATIENT HAD ITCHING AT THE BURR HOLE SITE AND AT THE DEVICE SITE AND THE SHOCKING WAS FIRST NOTICED WHILE ITCHING HIS HEAD WITH A BASEBALL HAT. IT WAS REPORTED THAT THE PATIENT'S THERAPY WAS DECENT BUT IT WAS HARD TO TELL BECAUSE THE PATIENT HAD RECENTLY TAKEN THEIR MEDICATION. HOWEVER , IT WAS NOTED THAT WHILE THE DEVICE WAS OFF THE PATIENT WAS UNABLE TO SPEAK AND HAD A "HORRIBLE TREMOR". IT WAS THEREFORE THOUGHT THAT THE PATIENT WAS STILL GETTING THERAPEUTIC BENEFIT. IT WAS ALSO NOTED THAT THERE MAY BE A CONNECTION ISSUE, FRACTURE, OR INSULATION BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152626 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1