BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4122411 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01652
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORP.
    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 ROOT CAUSE FOR THE REPORT OF GI BLEEDING COULD NOT BE DETERMINED THROUGH THIS EVALUATION. 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 TO THE HOSPITAL ON (B)(6) 2014 FOR A GI BLEED. HIS HEMOGLOBIN AT THAT TIME WAS 4.6. THE PATIENT UNDERWENT AN UPPER GI ENDOSCOPY WHICH REVEALED GASTRIC EROSION AND NO ACTIVE BLEEDING. THE PATIENT WAS TREATED WITH 4 UNITS OF PACKED RED BLOOD CELLS AND CARAFATE. HIS INR GOAL WAS 1.7-1.8. HIS HGB/HCT WAS 8.3/25 AT THE TIME OF DISCHARGE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579324 HEARTMATE II LVAS DSQ THORATEC CORP. 104911 110282

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention