BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3180515 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10655
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 30, 2013
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389S-40, LOT# VA072E3, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF. IT WAS NOTED THIS HAD OCCURRED ON THREE SEPARATE OCCASIONS. PATIENT STATED THERE WAS NO EVENT OR ENVIRONMENTAL INFLUENCE THAT WOULD HAVE CAUSED THE TURNING OFF. IT WAS NOTED THIS HAPPENED AROUND THE HOUSE. PATIENT WOULD NOTICE RETURN OF SYMPTOMS AND CHECK IMPLANTABLE NEUROSTIMULATOR (INS) WITH PROGRAMMER TO VERIFY THE INS HAD SHUT OFF. PATIENT WAS EXPERIENCING A LOSS OF THERAPY AND WAS UNABLE TO MOVE. IT WAS NOTED THERE WAS NO PATTERN TO WHEN THE INS TURNING OFF WOULD OCCUR. ADDITIONAL INFORMATION REPORTED STIMULATION WAS INTERMITTENT SINCE THE PATIENT RECEIVED THE NEW INS, LEAD AND EXTENSION. IT WAS NOTED PATIENT WOULD WAKE UP IN THE MORNING AND THE STIMULATION WOULD BE OFF. IT WAS NOTED REPORTS SHOWED STIMULATION ON/OFF TRIGGERS A CONSIDERABLE AMOUNT OF TIMES. THE STIMULATION TURNING ON AND OFF HAD STARTED 4 DAYS AFTER LAST INTERROGATION BY THE CLINICIAN PROGRAMMER. IT WAS FURTHER NOTED THE PATIENT WAS HAVING TROUBLE WITH THE DEVICE SINCE THE BEGINNING OF PROGRAMMING. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280179 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1