BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERLIN PROGRAMMER

    MDR report key: 6103577 · Received November 15, 2016

    Report

    Report Number
    2938836-2016-14046
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 6, 2016
    Report Date
    September 6, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    KRG
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP THE LONGEVITY OF THE BATTERY WAS ESTIMATED LONGER THAN EXPECTED. THE PATIENT WILL CONTINUE TO BE FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752923 MERLIN PROGRAMMER PACEMAKER PROGRAMMER KRG ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 3650

    Patients

    Seq Age Sex Outcome Treatment
    1