BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY ADX SR

    MDR report key: 3925710 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15219
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 14, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWP
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    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 ASYMPTOMATIC PATIENT HAD PRESENTED FOR FOLLOW-UP. THE PATIENTS LAST DEVICE CHECK WAS IN 2010. INTERROGATION OF THE PULSE GENERATOR SHOWED THAT THE DEVICE TO BE IN BACKUP MODE. THE DEVICE COULD NOT BE RESTORED DUE TO THE LOW BATTERY VOLTAGE AND THE PHYSICIAN PLANNED TO HAVE THE DEVICE EXPLANTED AND REPLACED ON A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404308 VERITY ADX SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5156 NA

    Patients

    Seq Age Sex Outcome Treatment
    1