BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3032458 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00358
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. NO FURTHER INFORMATION 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 COORDINATOR'S ADMINISTRATIVE ASSISTANT REPORTED THAT AFTER 21 MONTHS OF SUPPORT ON THE LVAD, THE PT HAD A DRIVE LINE INFECTION THAT REQUIRED IRRIGATION AND DEBRIDEMENT. THE CAUSE OF THE INFECTION WAS NOT REPORTED AND NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129897 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 103748

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention