BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4122420 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01647
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    May 29, 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 ISSUES HAVE BEEN REPORTED. A DIRECT RELATIONSHIP BETWEEN THE DEVICE AND THE REPORT OF GI BLEEDING COULD NOT CONCLUSIVELY 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 A GI BLEED. THE PATIENT'S HGB/HCT WERE 7.4/2.2 AT THAT TIME. THE PATIENT UNDERWENT AN EGD, COLONOSCOPY AND RED CELL SCAN. SHE ALSO RECEIVED TRANSFUSION WITH 6 UNITS OF PACKED RED BLOOD CELLS. IT WAS ALSO REPORTED THAT THE TREATMENT INCLUDED REDUCED TARGET INR. THE PATIENT'S HGB WAS 9.7 AT THE TIME OF DISCHARGE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579327 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 85198

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention