BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERLIN PROGRAMMER

    MDR report key: 6198726 · Received December 22, 2016

    Report

    Report Number
    2017865-2016-07979
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    October 22, 2016
    Report Date
    November 22, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    KRG
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING FOLLOW-UP THE DEVICE WAS AT ERI. THE LONGEVITY ESTIMATE PROVIDED BY THE PROGRAMMER AT PREVIOUS FOLLOW-UP OVERESTIMATED THE DEVICE LONGEVITY. THE DEVICE WAS REPLACED AND THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849400 MERLIN PROGRAMMER PACEMAKER PROGRAMMER KRG ST. JUDE MEDICAL, INC. 3650

    Patients

    Seq Age Sex Outcome Treatment
    1