BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY DR

    MDR report key: 2905227 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00800
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 19, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO A FOLLOW UP AND THE DEVICE EXHIBITED HIGH CURRENT DRAIN. THE LEADS WERE PROGRAMMED TO NORMAL OUTPUTS. THE PATIENT WOULD BE SCHEDULED FOR A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12208 VERITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 5356 NA

    Patients

    Seq Age Sex Outcome Treatment
    1