BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3841070 · Received May 14, 2014

    Report

    Report Number
    2916596-2014-00651
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE PUMP. THE DEVICE REMAINS IMPLANTED AND IN USE BY THE PT; HOWEVER, THE MFR IS ATTEMPTING TO ACQUIRE THE REPLACED PORTION OF THE PERCUTANEOUS LEAD FOR ANALYSIS. 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). APPROX 2 YEARS POST-IMPLANT, IT WAS REPORTED THAT THE PT HAD A RED HEART ALARM WHEN CONNECTED TO HIS POWER MODULE. IT WAS ALSO REPORTED THAT THE PT WAS NOT FEELING WELL; THEREFORE HE SWITCHED TO BATTERIES AND WENT TO THE HOSPITAL. AT THE HOSPITAL THE PT WAS CONNECTED TO A POWER MODULE AND A RED HEART AND LOW FLOW ALARM APPEARED. AN X-RAY WAS PERFORMED AND INDICATED DAMAGE ON THE PERCUTANEOUS LEAD NEAR THE BEND RELIEF AND THE MFR'S TECH SERVICE PERSONNEL PERFORMED A PERCUTANEOUS LEAD REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288010 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693 112439

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention