BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2699935 · Received August 15, 2012

    Report

    Report Number
    3004209178-2012-06904
    Event Type
    Malfunction
    Date Received
    August 15, 2012
    Report Date
    July 17, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V050681, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A TINGLING OR SHOCKING SENSATION ON THE OPPOSITE SIDE OF WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED. THE SHOCKING RUNS DOWN THE PATIENT'S ARM. THE PATIENT'S TREMOR WAS STILL CONTROLLED BUT IT HAD GOTTEN WORSE IN THE LAST COUPLE MONTHS. THE SHOCKING HAD OCCURRED SINCE THE INS WAS IMPLANTED, WHICH REPLACED ANOTHER ONE. THE TINGLING SENSATION WOULD USUALLY OCCUR WHEN DOING A MOVEMENT, ESPECIALLY WHEN THE PATIENT LIFTED HIS ARMS ABOVE HIS HEAD. WHEN THE AMPLITUDE WAS INCREASED A SHOCK DOWN HIS ARM WOULD OCCUR, BUT THEN IT WOULD GO AWAY. WHEN THE INS CONNECTOR BLOCK IS PUSHED ON, IT WOULD CAUSE A SHOCKING SENSATION. AN IMPEDANCE CHECK FOUND THAT ALL PAIRS WITH CONTACT 0 WERE ABOVE 40,000 OHMS. AN IMPEDANCE CHECK WAS DONE WITH THE INS PUSHED ON. THE DEVICE HAD "JIGGLED" WHILE PUSHING ON IT, AND IT WAS FOUND THAT THE PAIRS WITH CONTACT 0 CHANGED TO ABOUT 10,718 OHMS, WHILE THE OTHER PAIRINGS STAYED ABOUT THE SAME AS BEFORE PRESSING ON IT. IMPEDANCES INCREASED BACK TO ABOVE 40,000 OHMS WHEN THE INS WAS NOT PUSHED ON AGAIN. PALPATING AREAS OTHER THAN THE INS DIDN'T PRODUCE A RESPONSE. THE DEVICE WAS PROGRAMMED TO C+, 1-. THE DEVICE HAD AN INTERMITTENT CONNECTION ISSUE. NO FALLS OR TRAUMAS RELATED TO THE SYMPTOMS WERE REPORTED. TWO DAYS LATER IT WAS REPORTED THAT THE VOLTAGE ON THE CURRENT SETTING WAS INCREASED TO HELP THE PATIENT'S TREMOR HOWEVER THERE WAS NO ANSWER TO THE INTERMITTENT PARESTHESIA. IF THE PROBLEM PERSISTS THE PATIENT WILL GO TO THE OPERATING ROOM. NO X-RAY WAS DONE AS THE SUSPICION WAS A LOOSE SCREW ON THE NON-ACTIVE ELECTRODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1