BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3032473 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00341
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR;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 WAS RECENTLY ADMITTED INTO THE HOSPITAL FOR A DROP IN HEMOGLOBIN DUE TO CHRONIC ANEMIA (11.0 > 7.4 IN 4 WEEKS). A CAPSULE STUDY WAS CONDUCTED AND WAS NEGATIVE. THE PT'S HEMOGLOBIN WAS MONITORED FOR ANY OTHER INDICATIONS THAT MAY HAVE INDICATED A GI BLEED. THE PT WAS DISCHARGED TO HOME 6 DAYS LATER. PER ADDITIONAL INFORMATION RECEIVED FROM THE VAD COORDINATOR, THE PT HAD BEEN ADMITTED TWO MONTHS PRIOR TO THE REPORTED EVENT FOR A GI BLEED. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED AT THAT TIME AND SHOWED "OOZING OF BLOOD" IN THE PROXIMAL JEJUNUM. IT WAS TREATED WITH EPINEPHRINE AND WAS CAUTERIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129902 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111557

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention