BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL DR, DF-4 CONNECTOR

    MDR report key: 4153599 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16468
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR FOLLOW UP WITH DEVICE POST SENSED T WAVE OVERSENSING ON VENTRICULAR CHANNEL. PATIENT RECEIVED INAPPROPRIATE HV THERAPY. PROGRAMMING CHANGES WERE MADE DURING DEVICE CHECK. PATIENT WAS STABLE AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631462 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 72 YR Required Intervention