BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3962647 · Received July 16, 2014

    Report

    Report Number
    2916596-2014-01195
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT WAS INPATIENT ON BIVAL FOR TREATMENT OF A LVAD THROMBUS. THE PT WAS SITTING IN A CHAIR AT HIS BEDSIDE HAVING LUNCH (ON BATTERIES) WHEN HE NOTICED A SHORT ALARM. LOW SPEED AND PUMP STOP ALARMS WERE NOTED. THE PT WAS ASYMPTOMATIC AT THE TIME. THE PT DESCRIBED THE ALARM AS THE "SAME ALARM/SITUATION THAT OCCURRED A FEW WEEKS AGO WHILE AT ANOTHER HOSPITAL FACILITY. UPON REVIEW OF THE RECORDED LOG FILE HISTORY, THE PT WAS NOTED TO HAVE THE FOLLOWING EVENTS: LOW SPEED ADVISORY, PULSATILITY INDEX (PI) EVENT, PUMP OFF, PI EVENT, AND LOW SPEED ADVISORY. A REVIEW OF THE SUBMITTED LOG FILE DATA WAS CONSISTENT WITH THE REPORTED EVENT. IT WAS REPORTED THAT THE PT'S LACTATE DEHYDROGENASE LEVELS WERE IN THE 1500'S AND A PUMP EXCHANGE WAS PLANNED. THE PT SUBSEQUENTLY UNDERWENT A PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415350 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106105 139457

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention