BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITY DR

    MDR report key: 3802520 · Received May 9, 2014

    Report

    Report Number
    2017865-2014-13755
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 5, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PULSE GENERATOR EXHIBITED INAPPROPRIATE MEASURED DATA. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281338 VERITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC., CRMD 5356 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)