BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY DR

    MDR report key: 3920400 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14033
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    March 31, 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
    CA
    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 AN INCORRECT DEVICE LONGEVITY CALCULATION WAS OBTAINED FROM THE PULSE GENERATOR. INTERROGATION WITH A DIFFERENT PROGRAMMER YIELDED AN ACCURATE RESULT. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397403 VERITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5356 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR