BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 2875207 · Received December 13, 2012

    Report

    Report Number
    2916596-2012-01196
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 1 DAY POST-IMPLANT, THE SURGEON REPORTED THAT A DECISION WAS MADE TO EXCHANGE THE PUMP DUE TO INSUFFICIENT UNLOADING OF THE LEFT VENTRICLE, AS OBSERVED DURING AN ECHO. THE PUMP FLOW WAS RELATIVELY HIGH AT 8 LPM. POWER CABLE DISCONNECT ALARMS WERE ALSO REPORTED, DESPITE REPLACEMENT OF THE SYSTEM CONTROLLER, POWER MODULE (PM) AND PM PATIENT CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 119469

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention