BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2862192 · Received December 5, 2012

    Report

    Report Number
    2916596-2012-01183
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. 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 (LVAD). IT WAS REPORTED BY THE SURGEON THAT, IN THE PAST, THE PATIENT EXPERIENCED PERSISTENT PERCUTANEOUS LEAD INFECTIONS. THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO RELOCATE THE PERCUTANEOUS LEAD EXIST SITE TO THE OPPOSITE SIDE. ON (B)(4) 2012, ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE FROM ONE LVAD PUMP TO ANOTHER LVAD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 93333

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention