BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 6562370 · Received May 11, 2017

    Report

    Report Number
    2017865-2017-03248
    Event Type
    Injury
    Date Received
    May 11, 2017
    Date of Event
    April 4, 2017
    Report Date
    January 9, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA NUMBER P880086 SHOULD HAVE BEEN INCLUDED ON THE INITIAL MDR SUBMITTED ON 5/11/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCING HEART FAILURE SYMPTOMS AND SHORTNESS OF BREATH WAS ADMITTED TO THE HOSPITAL. UPON INTERROGATION, THE PULSE GENERATOR EXHIBITED LOSS OF OUTPUT. ISOMETRIC TESTING WAS PERFORMED AND REVEALED NO DEVICE OVERSENSING. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION AND WOULD CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341835 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5816 0002132360

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization