BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 2885061 · Received December 19, 2012

    Report

    Report Number
    2916596-2012-01212
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 21, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER 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. APPROX 1.5 YEARS POST-IMPLANT, THE PT REPORTED RED HEART ALARMS WHILE CONNECTED TO THE POWER MODULE. THE VAD COORDINATOR ADVISED THE PT TO GO TO THE OUTPATIENT CLINIC, WHERE THE RED HEART ALARMS WERE REPRODUCED. THE MEDICAL TECHNICIAN FROM THE OUTPATIENT CLINIC OPENED THE SILICONE SLEEVE OF THE PERCUTANEOUS LEAD APPROX 0.5 CM AND OBSERVED NO FLUID INSIDE OF THE SLEEVE; THEREFORE, AN EVAL BY THE MANUFACTURER'S TECHNICAL SUPPORT TEAM WAS SCHEDULED FOR THE FOLLOWING DAY. UPON VISUAL INSPECTION AND ELECTRICAL TESTING OF THE PERCUTANEOUS LEAD, A DECISION WAS MADE TO EXCHANGE THE PUMP DUE TO SUSPECTED DAMAGE TO THE INTRACORPOREAL PORTION OF THE PERCUTANEOUS LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 104037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention