BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2433479 · Received January 9, 2012

    Report

    Report Number
    2916596-2012-00025
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    December 17, 2011
    Report Date
    December 17, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IMPLANTED SUPPORTING THE PT. NO FURTHER INFO 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 EXPERIENCED A RED HEART ALARM WHILE REMOVING THE SYSTEM CONTROLLER FROM HIS BAG. THE PT NOTICED A TEAR IN THE AREA OF THE SILASTIC/METAL JUNCTION OF THE DRIVELINE. THIS HAD OCCURRED A FEW TIMES PRIOR TO THIS EVENT. THE PT DID NOT HAVE ANY OTHER ISSUES AND WAS NOT SYMPTOMATIC DURING THE EVENT. THE PT WENT TO THE HOSPITAL THE FOLLOWING DAY AND MORE RED HEART ALARMS OCCURRED. NO DATA WAS PRESENT ON THE SCREEN; HOWEVER, THE VAD COORDINATOR FELT THAT THE PUMP WAS RUNNING. IT WAS THEN NOTED THAT THERE WERE LOW FLOW, LOW SPEED AND PUMP OFF ALARMS. THE PT'S PERCUTANEOUS LEAD WAS THEN REPAIRED WITH THE MFR'S REPAIR KIT. THE PT IS ONGOING WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 84977

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention