BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 1990694 · Received February 8, 2011

    Report

    Report Number
    2916596-2011-00059
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THERE WAS A CUT IN THE PNEUMATIC LINE BETWEEN THE PUMP CASING AND THE "Y" CONNECTOR. THE CUT WAS FILLED WITH SILICONE ADHESIVE AND THE PNEUMATIC LINE SECURELY WRAPPED WITH RESCUE TAPE. A PUMP EXCHANGE WAS PLANNED FOR THE FOLLOWING DAY. NO OTHER INFO IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention