BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 1215648 · Received October 14, 2008

    Report

    Report Number
    2916284-2008-00004
    Event Type
    Other
    Date Received
    October 14, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 14, 2008
    Manufacturer
    WORLD HEART, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RECIPIENT REPORTED A TEAR IN THE PERCUTANEOUS LEAD VENT TUBE AND THEN WATER IN VENT TUBE COVERING AFTER SHOWERING. ALTHOUGH THERE WAS NO IMPACT TO PUMP PERFORMANCE, AS A PRECAUTION, THE PT WAS LISTED AS (B) (6) ON THE TRANSPLANT LIST "DUE TO DEVICE COMPLICATION". WORLDHEART HAS PROVIDED REPAIR MATERIALS REGARDING THE VENT TUBE TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM PUMP/DRIVE UNIT DSQ WORLD HEART, INC. 0317051764

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other