BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUSTAIN XL DC

    MDR report key: 6034395 · Received October 17, 2016

    Report

    Report Number
    2017865-2016-06609
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR PULSE GENERATOR CHECK, THERE WAS A NON-SUSTAINED (A FEW SECONDS) EPISODE THAT SEEMED TO BE - PACEMAKER-MEDIATED TACHYCARDIA -. NO REPROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE AND WOULD BE REASSESSED AT ROUTINE FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684181 SUSTAIN XL DC IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) PM2134 4186953

    Patients

    Seq Age Sex Outcome Treatment
    1