BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6142566 · Received December 2, 2016

    Report

    Report Number
    3004209178-2016-25078
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT HAS BEEN COMPLAINING OF FEELING AN INTERMITTENT TINGLING SENSATION AT THE POCKET SITE WHEN THEY TURN THEIR HEAD TO THE RIGHT SIDE, WITH IT NOTED THAT IT IS THE RIGHT SC FOR VIM. ELECTRICAL IMPEDANCES WERE CHECKED WITH THE PATIENT TURNING THEIR HEAD TO THE RIGHT WITH THE FOLLOWING OUT OF RANGE: C0 = 2476, C1 = 2264, 01 = 3531, 03 = 3514, 13 = 3244, WITH THE PATIENT PROGRAMMED AT C+ 2- 2V/60PW/130HZ. NO TINGLING SENSATIONS OCCURRED WHEN IMPEDANCES WERE CHECKED. HOWEVER, WHEN THE POCKET SITE WAS PRESSED AND THE PATIENT'S HEAD WAS TURNED TO THE RIGHT, THEY FELT A TINGLING SENSATION IN THEIR LEFT HAND WITH THE FOLLOWING HIGH IMPEDANCES: C0 = 2493, C1 = 2271, 01 = 3559, 02 = 2767, 03 = 3514, 13 = 3244. THE LAST EPISODE FOR THE PATIENT WAS ON (B)(6) 2016, AND FOLLOW UP WITH THE HEALTHCARE PROVIDER (HCP) IS TO BE CONDUCTED. ON NOV-15 THE REP CONFIRMED THE TINGLING WAS PRESENT FOR 1-2 SECONDS AND THEN DIMINISHED AND DID NOT COME BACK. THE CAUSE OF THE INTERMITTENT TINGLING WAS BECAUSE THEY WERE DOING AN IMPEDANCE CHECK ON THE RIGHT LEAD AT 3V CAUSING THE SIDE EFFECT FOR THE PATIENT. THE TINGLING SENSATION RESOLVED ALMOST IMMEDIATELY AFTER THE PATIENT MENTIONED IT AND IT WAS GONE. THE PATIENT'S INDICATION FOR IMPLANT IS ESSENTIAL TREMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792219 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1