BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL II

    MDR report key: 1213802 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06806
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S STIMULATION HAD TURNED OFF TWICE IN THE PAST TWO WEEKS. THE PATIENT STATED HE HAS ONLY HAD THE DEVICE TURN OFF ONE OTHER TIME APPROXIMATELY 1 YEAR AGO. THE CURRENT BATTERY MEASUREMENT WAS 3.67, CONSIDERED ACCEPTABLE AS IT IS GREATER THAN 3.3 V. LONGEVITY TESTS WERE PERFORMED AND BASED ON THE PATIENT'S CURRENT SETTINGS, THE DEVICE COULD POTENTIALLY LAST 27 YEARS. THE DEVICE WAS CURRENTLY SET TO 1.5V, 450PW, 33 RATE AND UNIPOLAR WITH ONE CATHODE PROGRAMMED. THE PATIENT USES THE DEVICE APPROXIMATELY 4 HOURS A DAY AND CYCLES 10 SECONDS ON WITH 5 SECONDS OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7496-51| EXPLANTED:| LEAD: MODEL 3586| IMPLANTED: