BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2143047 · Received June 23, 2011

    Report

    Report Number
    2916596-2011-00256
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). THE VAD COORDINATOR REPORTED THAT THE PATIENT PRESENTED WITH A SIGNIFICANT DRIVELINE INFECTION. IT WAS ALSO REPORTED THAT WHILE THE LVAD HAS NOT SHOWN ANY SIGNS OF A DEVICE MALFUNCTION, THE PERCUTANEOUS LEAD WAS VISIBLY KINKED AND TWISTED IN SEVERAL AREAS. THE PATIENT REMAINS UNDER OBSERVATION IN THE HOSPITAL AWAITING A DECISION BY THE HOSPITAL WHETHER TO EXCHANGE THE LVAD WITH ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 77330

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization