BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCENT DR

    MDR report key: 6108370 · Received November 16, 2016

    Report

    Report Number
    2938836-2016-14316
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    June 12, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED TO CLINIC FOR ROUTINE FOLLOW UP, EPISODES OF VENTRICULAR NOISE WAS OBSERVED ON THE NOISE. PATIENT IS DEPENDENT ON PACING. PROGRAMMING CHANGES WERE MADE. PATIENT WAS STABLE AND WILL BE MONITORED WITH ROUTINE FOLLOW UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755772 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) PM2110 3410503

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR