BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURRENT ACCEL DR, DF-4 CONNECTOR

    MDR report key: 3884809 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12169
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER AN EPISODE OF VENTRICULAR LEAD NOISE WAS OBSERVED VIA REMOTE TRANSMISSION. THE NOISE WAS REPRODUCED IN CLINIC. MYOPOTENTIAL OVERSENSING WAS SUSPECTED. DEVICE INTERROGATION REVEALED MULTIPLE AUTOMODE SWITCH EPISODES DUE TO NOISE ON THE ATRIAL LEAD. THE DEVICE WAS REPROGRAMMED. FOLLOW-UP WILL CONTINUE.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTED SOME FAR R SENSING TOO BUT EXTENDED (PVAB) POST-VENTRICULAR ATRIAL BLANKING PERIOD TO REDUCE FAR R. THE PATIENT WILL CONTINUE WITH FOLLOW UPS. PATIENT IS FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359836 CURRENT ACCEL DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2215-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR