BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2181375 · Received July 21, 2011

    Report

    Report Number
    2916596-2011-00301
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL 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 BY THE VAD COORDINATOR THAT THE PT WAS EXPERIENCING SPEED CHANGES BELOW THE LOW SPEED LIMIT WHEN PLUGGED INTO THE POWER MODULE PT CABLE. THE EVENT WOULD NOT OCCUR WHEN THE PERCUTANEOUS LEAD WAS MANIPULATED, HOWEVER, WHEN THE PT LEANED FORWARD, THE EVENT WOULD OCCUR. WAVEFORMS AND THE LOG FILE WERE SENT TO THE MFR FOR REVIEW AS THE SHIELD SHORTING TO GROUND WAS SUSPECTED. THE PT WAS PLACED ON BATTERIES FOR 24 HOURS WITHOUT INCIDENT. THE X-RAY REVEALED AN AREA EXTERNAL TO THE PT, ABOUT FOUR INCHES FROM THE SYSTEM CONTROLLER ON THE PERCUTANEOUS LEAD THAT DID NOT LOOK UNIFORM, ALTHOUGH, THE SHIELDING WAS INTACT. IN ADDITION, A LOOP WAS SEEN WHICH DID NOT APPEAR TO HAVE ANY STRESS AREAS. A CONTINUITY TEST WAS PERFORMED ON THE PERCUTANEOUS LEAD AND IT PASSED TESTING. THE LEAD WAS THEN MANIPULATED WHICH DID NOT RESULT IN ANY ABNORMALITIES OR RECREATE THE EVENT, BUT WHEN THE PT LEANED FORWARD A "WARNING LOW SPEED OPERATION" AND SPEED CHANGE TO THE 5000 RPM'S WERE NOTED ON THE SCREEN AND RECORDED ON THE HISTORY SCREEN. A LVAD PUMP EXCHANGE WAS SCHEDULED FOR THE FOLLOWING MORNING. UPDATED INFO RECEIVED 5 DAYS LATER INFORMED THE MFR THAT THE LVAD PUMP HAD BEEN SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD PUMP. DURING THE LVAD EXCHANGE, THE SURGEON NOTED THAT AN EXTRA BONE WAS GROWING FROM THE PT'S STERNUM THAT WAS CLOSE TO THE PERCUTANEOUS LEAD AND IT WAS THOUGHT THAT WHEN THE PT WOULD BEND FORWARD, THIS EXTRA BONE WOULD PUSH AGAINST THE PERCUTANEOUS LEAD AND IT WAS SUSPECTED THAT IT WAS WEARING THROUGH THE PERCUTANEOUS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 88043

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention