BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3940327 · Received June 19, 2014

    Report

    Report Number
    2916596-2014-01019
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT'S PUMP WAS EXCHANGED. THE PT HAD RECEIVED A PUMP EXCHANGE IN (B)(6) (MFR REPORT NUMBER 0002916596-2014-00294) DUE TO NONCOMPLIANCE WITH LOVENOX AND THE HOSPITAL FEELS HE IS THROMBOSING AGAIN. HIS LDH WAS 1200. THEY TRIED INTRAVENTRICULAR TPA AND IT DIDN'T SEEM TO HELP. THE PUMP WAS EXCHANGED FOR ANOTHER MANUFACTURERS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360775 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 136667

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention