BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2950607 · Received February 5, 2013

    Report

    Report Number
    2916596-2013-00149
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED. THE USER FACILITY REPORT WAS REC'D FROM THE (B)(4) REGISTRY.

    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 WHILE AT HOME, THE PT EXPERIENCED A RED WRENCH AND AUDIBLE ALARM ON THE POWER MODULE. NO SYS CONTROLLER ALARMS WERE REPORTED. THE PT CHANGED FROM BEING TETHERED OVER TO BATTERIES POWER AND POWER LEAD DISCONNECT ALARMS BEGAN. THE PT THEN CHANGED HIS SYS CONTROLLER, SO HE SWITCHED BACK TO ORIGINAL SYS CONTROLLER. THE PT CAME TO HOSP AFTER PASSING OUT AT HOME. AT THE HOSP, THE POWER MODULE AND PT CABLE WAS CHANGED OUT. IT WAS NOTED THAT THERE MAY BE A BROKEN PIN IN ONE OF THE BATTERY CLIPS WHICH MAY HAVE CAUSED THE POWER CABLE DISCONNECT ISSUE. THE PT REMAINED IN THE HOSPITAL FOR TROUBLESHOOTING, AND DURING THIS TIME WHILE EITHER ON BATTERY OR TETHERED TO THE HOSP POWER MODULE, THE PT DID NOT EXPERIENCE ANY ALARMS. THE PERCUTANEOUS LEAD WAS MANIPULATED SOME, BUT NO ALARMS OCCURRED. IT WAS NOTED THAT THE PUMP SOUNDED GOOD. ADD'L INFO REC'D 6 DAY LATER CONFIRMED THAT A BROKEN PIN FROM THE SYS CONTROLLER HAD BROKEN OFF INSIDE ONE OF THE BATTERY CLIPS. IN ADDITION, THE POWER MODULE BACK UP BATTERY WAS EXCHANGED AND THE REPORTED ALARMS CLEARED. THE POWER MODULE PASSED THE SELF-TEST AND WAS WORKING CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49356 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 96843

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention