BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4006497 · Received August 13, 2014

    Report

    Report Number
    3004209178-2014-15257
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# V109673, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V130326, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S THERAPY WAS DOING WELL BUT IMPEDANCES HAD BECOME A CONCERN AND WORSENED IN (B)(6) 2013, POST IMPLANTABLE NEUROSTIMULATOR (INS) CHANGE-OUT. IMPEDANCE VALUES WERE AS LISTED: THERAPY IMPEDANCE WAS 2097 OHMS IN MARCH, THERAPY IMPEDANCE WAS ¿HIGH¿ IN JULY OF LAST YEAR, ALL COMBINATIONS WITH 2 WERE ABOVE EXPECTED LEVELS IN (B)(6) 2014: C2 3996 OHMS, 02 5244 OHMS, 12 4638 OHMS, THERAPY IMPEDANCE WAS 1151 (NORMAL) IN (B)(6) 2014, AND THERAPY IMPEDANCE WAS ¿HIGH¿ ON (B)(6) 2014. THERE HAD BEEN NO REPORTS OF FALLS OR TRAUMA PRIOR TO CONCERN REGARDING IMPEDANCES. IT WAS NOTED THAT THE PATIENT DID STRETCHING, YOGA, AND DANCE. THE IMPEDANCE ISSUES SEEMED TO BE INTERMITTENT AND IT WAS STATED THAT IMPEDANCES WOULD BE CHECKED WHILE THE PATIENT WAS IN DIFFERENT POSITIONS THE NEXT TIME THE PATIENT WAS SEEN IN THE OFFICE. AT THE END OF THE CALL THERAPY WAS REPORTED TO BE DOING WELL AND THE IMPEDANCE PROBLEM WAS UNRESOLVED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481357 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR