BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2930915 · Received January 24, 2013

    Report

    Report Number
    2916596-2013-00088
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 26, 2012
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED INFORMATION VIA THEIR DEVICE TRACKING SYSTEM THAT A PUMP EXCHANGE HAD TAKEN PLACE ON (B)(6) 2012. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION ADVISING THAT THE PT HAD A SYNCOPE EPISODE WHILE AT HOME. UPON ADMISSION TO THE HOSPITAL, THE ECHO CARDIOGRAM (ECHO) REFLECTED A DECREASE IN FLOW AND THROMBUS WAS SUSPECTED. A DECISION WAS MADE TO EXCHANGE THE LVAD PUMP FOR ANOTHER LVAD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33740 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104911 104036

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention