BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2052150 · Received March 1, 2011

    Report

    Report Number
    2916596-2011-00076
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS UNABLE TO CONDUCT AN INVESTIGATION OF THE DEVICE, BECAUSE IT WAS NOT RETURNED BY THE HOSPITAL. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PUMP WAS EXCHANGED DUE TO A PUMP POCKET INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 83038

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention