BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTHEM RF CRT-P

    MDR report key: 6487800 · Received April 12, 2017

    Report

    Report Number
    2017865-2017-02234
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    December 1, 2016
    Report Date
    July 24, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NKE
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF FALSE ERI/EOS ALERTS WAS CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE REVEALED THAT ERI STATUS WAS STILL SET TO BOL AND RECORDED BATTERY VOLTAGE REMAINED ABOVE ERI DURING IMPLANT DURATION. POSTPONED MONTHLY VOLTAGE MEASUREMENTS WERE LIKELY CAUSED BY EXCESSIVE TELEMETRY USAGE. THE DEVICE WAS TESTED ON THE BENCH AND NO ANOMALIES WERE FOUND. AFTER RELOADING FIRMWARE TO CLEAR ERI AND EOS ALERTS, FURTHER ANALYSIS DETERMINED NORMAL BATTERY DEPLETION. THE CAUSE OF THE FALSE ERI/EOS ALERTS COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR NORMAL ERI IT WAS NOTED THAT ALERTS FOR EOS AND ERI HAD BEEN INAPPROPRIATELY TRIGGERED IN PAST. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269711 ANTHEM RF CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR NKE ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM3210 3626566

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR