BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6050570 · Received October 24, 2016

    Report

    Report Number
    3004209178-2016-22350
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    February 1, 2015
    Report Date
    October 24, 2016
    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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# VA0405A, IMPLANTED: 2B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V961943, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT IS EXPERIENCING SHOCKING SENSATION AS OF THE LAST 4 OR 5 DAYS PRIOR TO DATE NOTIFIED. IT WAS STATED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) IN THE LEFT PECTORAL IS GETTING INTERMITTENT SHOCKING SENSATION THAT RADIATES TO THE AXILLA, AND THAT THERE ARE NO ISSUES WITH THE RIGHT INS. THERE WAS NO LOSS OR CHANGE OF STIMULATION. IMPEDANCE MEASUREMENTS WERE TAKEN, AND THE IMPLANT WAS CONFIRMED TO BE ON. IT WAS NOTED THAT THE PATIENT HAD FALLEN ON A FISH TANK ON (B)(6) 2016 WITH NO BRUISING, SWELLING, OR INDICATION THAT THERE IS A DEVICE INJURY. PALPATING WAS ATTEMPTED AROUND THE INS BUT THEY WERE UNABLE TO RECREATE THE SHOCKING. THE SHOCKING IS VERY RANDOM AND SPORADIC AND IT IS HAPPENING WHEN LYING DOWN AND WHEN GETTING UP FROM THE EXAM CHAIR. WHEN THE INS IS OFF, NO SHOCKING SYMPTOMS ARE EXPERIENCED, AND THE PATIENT IS SHOWING THAT THE DEVICE WAS OFF FROM 12:30-2:30PM AND FROM MIDNIGHT TO 5AM. THE PATIENT HAD COMPLAINED OF VERACIOUS SHOCKS LIKE THINGS OVER THE YEARS BUT THEY ALWAYS SEEM TO GO AWAY, AND MAY BE DUE TO ANXIETY ISSUES. HOWEVER, THE HCP CONFIRMED THE PATIENT ISN'T ALWAYS HONEST ABOUT THIS. THE ACTIVE PARAMETERS WERE NOTED AS LEFT- 3+, 2-, 1-, 4.2V, 110PW, 140HZ, AND RIGHT SIDE IS 9-, 8+, 4.2V, 110PW, 140HZ. IMPEDANCES WERE TAKEN AND FOUND TO BE NORMAL, EXCEPT C/0 WHICH SHOWED AS 2902 OHMS WHICH IS STILL WITHIN RANGE. IT WAS NOTED THAT THE HCP TENDS TO IMPLANT LEADS A BIT DEEP SO 0 TENDS TO TEST ABNORMAL, AND IF THE 0 CONTACT IS USED WITH THE PATIENT THEY WILL HAVE SIDE EFFECTS. THE LAST IMPEDANCE CHECK WAS IN (B)(6) 2015 WHERE C/0 WAS 2512 OHMS. THE PATIENT'S INDICATION FOR IMPLANT IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703599 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR