BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4960916 · Received August 3, 2015

    Report

    Report Number
    3004209178-2015-14528
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Report Date
    July 15, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2015 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V043266, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V094223, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TINGLING ON ONE SIDE WHEN STIMULATION WAS ON; IT WAS AS THOUGH SHE WAS GETTING TOO MUCH STIMULA TION. TINGLING WOULD STOP FOR A LITTLE BIT BUT MOST OF THE TIME THE PATIENT FELT TINGLING WHEN STIMULATION WAS ON. THE QUALITY OF THE STIMULATION THERAPY HAD NOT CHANGED AND THE PATIENT WAS RECEIVING THERAPEUTIC BENEFIT. . THE TINGLING STARTED ABOUT A WEEK AGO FROM (B)(6) 2015. IMPEDANCE MEASUREMENTS WERE TAKEN AND THEY WERE ALL UNDER 2 ,000 OHMS AND WERE NORMAL. THE READINGS WERE 0C-814, 1C -896, 2C- 1177, 3C-923, 01-826, 02- 1177, 03-1094 ,12- 1094 ,13-1131 AND 23 1148. THE PATIENT HAD WORSENING OF SPEECH BUT THE HEALTH CARE PROVIDER (HCP) DID NOT THINK IT WAS RELATED TO THE DBS THERAPY. REPROGRAMMING WAS GOING TO BE TRIED AND VOLTAGE WAS GOING TO BE POSSIBLY REDUCED AS THE PATIENT MAY HAVE BEEN GETTING TOO MUCH STIMULATION. THE PATIENT HAD SOME TINGLING AT 2V-2.5V WHEN USING 0-C+ BUT THE SENSATION WOULD GO AWAY WHEN THE VOLTAGE WAS INCREASED ABOVE 2.5V. THE SAME THING WAS SEEN WITH OTHER ELECTRODE PAIRS. AN OUT OF REGULATION (OOR) ERROR CODE WAS SEEN ON THE PATIENT PROGRAMMER ABOUT A WEEK AGO FROM (B)(6) 2015. THE OOR WAS SEEN WHEN THE PATIENT WAS TRYING TO TURN THE STIMULATION OFF WHICH SHE USUALLY DID AT NIGHT. THE OOR MESSAGE SHOWED AGAIN ON THE PATIENT PROG RAMMER IN THE CLINIC TODAY ((B)(6) 2015). THE HCP TRIED TURNING STIMULATION ON AND OFF BUT THE OOR DID NOT GO AWAY. THE DEVICE WAS SET ON THE VOLTAGE PROGRAMMING MODE AND THE THERAPY IMPEDANCES WERE 1065 OHMS. IT WAS NOTED THAT IT WAS UNLIKELY THAT OOR WAS BEING CAUSED BY SETTINGS GIVEN THAT THERAPY IMPEDANCE WAS 1065 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505915 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR