BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERLIN PROGRAMMER

    MDR report key: 6239676 · Received January 10, 2017

    Report

    Report Number
    2938836-2017-02335
    Event Type
    Malfunction
    Date Received
    January 10, 2017
    Date of Event
    December 23, 2015
    Report Date
    October 11, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    KRG
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THROUGH MERLIN.NET TRANSMISSION, AN UNEXPECTED DECREASE IN DEVICE LONGEVITY WAS OBSERVED. ON (B)(6) 2015 REMOTE TRANSMISSION, BATTERY LONGEVITY WAS 3.7-3.9 YEARS. ON ANOTHER TRANSMISSION ON (B)(6) 2016, ESTIMATED LONGEVITY WAS 2.0 YEARS. ST. JUDE MEDICAL TECHNICAL REPRESENTATIVE PERFORMED IN-HOUSE CALCULATIONS AND EXPLAINED THAT THE DEVICE OVER-ESTIMATED THE LONGEVITY IN (B)(6) 2015. IT WAS CLOSER TO 2.0-2.75 YEARS IN (B)(6) 2015. NOW, THE PROGRAMMER DISPLAYED ESTIMATE OF 1.3 YEARS REMAINING TO ERI AND IT SHOULD BE ACCURATE FROM THIS POINT ONWARD. THE PATIENT WILL CONTINUE TO BE FOLLOWED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21889 MERLIN PROGRAMMER PACEMAKER PROGRAMMER KRG ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 3650

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR