BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICTORY XL SR

    MDR report key: 5606598 · Received April 25, 2016

    Report

    Report Number
    2017865-2016-02426
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    March 30, 2016
    Report Date
    October 1, 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
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PMA# SHOULD HAVE BEEN P880086 RATHER THAN BLANK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. DEVICE INTERROGATION REVEALED THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR, ERI ON (B)(6) 2016. THE PATIENT'S CONDITION WAS STABLE. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2016. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260178 VICTORY XL SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5610 0002350369

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention