BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRICULAR ASSIST DEVICE

    MDR report key: 2903456 · Received January 4, 2013

    Report

    Report Number
    2916596-2012-01288
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE RVAD WAS LEAKING AIR. THE PATIENT RECEIVED A PUMP EXCHANGE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4379 VENTRICULAR ASSIST DEVICE DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 107378

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention