BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHYR XL DR

    MDR report key: 4790156 · Received May 22, 2015

    Report

    Report Number
    3010215456-2015-00173
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW, OUT OF RANGE, VENTRICULAR LEAD IMPEDANCE WAS NOTED. THE PHYSICIAN ELECTED TO MAKE ANY CHANGES AND DECIDED TO MONITOR THE PATIENT ONLY. THE PATIENT¿S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333986 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC. (CRM-KISTA) 5826 3713537

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention