BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5191972 · Received October 30, 2015

    Report

    Report Number
    3004209178-2015-21914
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 10, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 387S-40, LOT# V130906, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER REPORTED THE SCREEN ON THE PATIENT PROGRAMMER WAS NOT VISIBLE. THE PATIENT COULD HEAR THE PROGRAMMER BEEP RAPIDLY, BUT THERE WAS NOTHING ON THE SCREEN. BATTERIES IN THE PROGRAMMER HAD BEEN CHANGE THREE TIMES. AT THE TIME OF THIS REPORT, THE PATIENT'S THERAPY WAS NOT ON, THE PATIENT HAD NO THERAPEUTIC EFFECT, AND THEIR SPEECH AND BODY MOVEMENTS WERE BEING AFFECTED. THE SYMPTOMS STARTED THE DAY OF THIS REPORT. IN (B)(6) 2012 THE PATIENT'S IMPLANTABLE NEUROSTIMULATORS WERE REPLACED DUE TO NORMAL BATTERY DEPLETION AND THEY NEVER RECEIVED A PATIENT PROGRAMMER. THE PATIENT'S INDICATION FOR USE IS MOVEMENT DISORDERS AND PARKINSON'S DUAL. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723076 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR