BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1820103 · Received August 25, 2010

    Report

    Report Number
    2916596-2010-00220
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 1, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO PROVIDED TO THE MFR INDICATED THAT THE PT CONTINUES TO DO WELL AT HOME POST-EXPLANT OF THE LVAD. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. 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). THE VAD COORD REPORTED THE PT'S LVAD HAD STOPPED FOLLOWING HIGH PUMP POWER SURGES. AN ECHOCARDIOGRAM (ECHO) PERFORMED BY THE HOSPITAL REVEALED LACK OF FLOW THROUGH THE DEVICE. THE PT WAS REPORTEDLY DOING WELL, REMAINED ASYMPTOMATIC AND DECLINED A PUMP REPLACEMENT. THE LVAD WAS TURNED OFF PENDING A DECISION WHETHER TO EXPLANT THE DEVICE AFTER FURTHER EVAL OF THE PT'S CARDIAC FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 71143

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization