BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY ADX XL

    MDR report key: 3920717 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14309
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 22, 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
    CN
    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 DURING IMPLANT, THE SETSCREW OF THE PULSE GENERATOR COULD NOT BE TIGHTENED. THE DEVICE WAS NOT USED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396365 VERITY ADX XL IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5256 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR