BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 1180903 · Received September 23, 2008

    Report

    Report Number
    2916284-2008-00003
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 23, 2008
    Manufacturer
    WORLD HEART, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A VISIT IN 2008 BY TECHNICAL SUPPORT, IT WAS DETERMINED THAT PHYSICAL FLEXING/MANIPULATION OF THE PERCUTANEOUS LEAD WOULD INDUCE A TRANSIENT SHORT TO THE SHIELD LEADING TO A CAPACITOR VOLTAGE OUT OF RANGE ALARM. THE LEAD WAS SUCCESSFULLY REPAIRED ON-SITE, AND PUMP PERFORMANCE WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM PERCUTANEOUS LEAD DSQ WORLD HEART, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention