BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3072370 · Received April 19, 2013

    Report

    Report Number
    2916596-2013-00452
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    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 ABOUT 4 MONTHS PREVIOUS THE PATIENT STARTED HAVING SYNCOPE (FAINTING). AT THAT TIME MANY ECHOCARDIOGRAMS' (ECHO'S) INCLUDING RAMP STUDIES WERE PERFORMED. MEDICAL MANAGEMENT WAS CHANGED BY STOPPING COREG. IN THE LAST MONTH, THE PATIENT HAS BEEN FEELING WELL. THE HOSPITAL TEAM QUESTIONED PUMP PLACEMENT AND IF THE PUMP WAS WORKING PROPERLY. A RAMP STUDY WAS PERFORMED WHICH DID NOT SHOW GREAT DECOMPRESSION OF THE LEFT VENTRICLE. A LEFT VENTRICULOGRAPHY (LV GRAM) WAS ATTEMPTED, BUT THE PATIENT'S AORTIC VALVE WAS FUSED ENOUGH THAT A WIRE TO INJECT DYE COULD NOT PASS THROUGH. THE PATIENT WAS PLACED ON 1A STATUS UNTIL IT COULD BE DETERMINED IF THE PUMP HAD A MALFUNCTION. SUBSEQUENTLY, THE PATIENT RECEIVED A HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170480 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 104111

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention