BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4122418 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01645
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER RELATED EVENTS HAVE BEEN REPORTED. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED INFECTION COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 FOR HAVING THIN, TAN COPIOUS AMOUNTS OF DRAINAGE FROM THE EXIT SITE OF THE DRIVELINE. THE PATIENT WAS FOUND TO HAVE A (B)(6) AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2014 AND REMAINS ON DOXYCYCLINE, AN IV ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579286 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 125083

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention