BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3796537 · Received May 7, 2014

    Report

    Report Number
    3004209178-2014-08639
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Report Date
    April 17, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA0C4XS, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD STARTED TO FEEL A SHOCKING SENSATION IN THE POCKET WHEN HE RAISED HIS ARM. IT WAS NOTED THAT THE PROBLEM BEGAN A COUPLE OF DAYS PRIOR TO THE DATE OF THIS REPORT. THE SHOCKING WAS CLOSER TO THE ARMPIT ON THE LATERAL SIDE OF THE POCKET. IT WAS NOTED THAT THE DEVICE WAS IMPLANTED IN THE VENTRAL INTERMEDIATE NUCLEUS (VIM) AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON THE LEFT SUB-CLAVICULAR. IT WAS NOTED THAT WHEN THE INS WAS TURNED OFF THE SHOCKING WAS NOT FELT, ALSO WHEN THE DEVICE IS PALPATED AND THERAPY IS ON THE SHOCKING WAS NOT FELT. PATIENT¿S SETTINGS WERE 1.4V, 90 PW, 180 HZ, C+2-3- AND THERAPY IMPEDANCE WAS 947 OHMS 1.5V. C/0 WAS 1108 OHMS, C/1 WAS 1015 OHMS, C/2 WAS 1066 OHMS, C/3 WAS 1170 OHMS, 0/1 WAS 1305 OHMS, 0/2 WAS 1702 OHMS, 0/3 WAS 1959 OHMS, 1/2 WAS 1244 OHMS, 1/3 WAS 1637 OHMS AND 2/3 WAS 1296 OHMS. ADDITIONAL INFORMATION RECEIVED REPORTED X-RAYS WERE TAKEN AND THERE WAS NO VISIBLE ISSUE WITH THE INS. NO MALFUNCTIONS WERE SEEN OR CAUSE DETERMINED. NO INTERVENTIONS WERE TAKEN OR PLANNED. THE PATIENT WAS GOING TO BE SEEN AGAIN BY THEIR HEALTHCARE PROFESSIONAL ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273910 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR