BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL DR

    MDR report key: 3923878 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14805
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP OF AN ASYMPTOMATIC PATIENT, THE PULSE GENERATOR WAS FOUND TO BE OPERATING IN BACKUP MODE. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2014 DUE TO AN ELECTIVE REPLACEMENT INDICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401695 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5816 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention