BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4122428 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01584
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    July 25, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE HOSPITAL REPORTED THAT THE PATIENT WAS ADMITTED FOR UPPER GASTROINTESTINAL BLEEDING ON (B)(6) 2014. THE PATIENT RECEIVED A BLOOD TRANSFUSION 6.00 PRBC. THE ISSUE RESOLVED ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD A SMALL BOWEL BLEED, WHICH WAS DETERMINED TO BE AVMS, WHICH WERE CLIPPED. THE DOCTOR SAID THIS WAS "PROBABLY/POSSIBLY" RELATED TO DEVICE. THE DEVICE WAS FUNCTIONING AS INTENDED AT THE TIME. THE DOCTOR PRESUMES ALL AVM BLEEDS RELATED TO DEVICE, BECAUSE OF THE INCREASED INCIDENCE IN VAD PATIENTS AND THE COUMADIN DOSE/INR RANGE NEEDED. THIS PATIENT HAD A RECENT HEMOLYSIS EVENT JUST PRIOR TO BLEED AND IT WAS NOT THOUGHT PRUDENT TO REDUCE HIS THERAPEUTIC RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579257 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 123083

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention