BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3950519 · Received July 11, 2014

    Report

    Report Number
    2916596-2014-01161
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNING FOR EVALUATION, AS THE HOSPITAL DISPOSED OF IT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A SPECIFIC CAUSE FOR THE REPORTED DRIVELINE INFECTION AND A CORRELATION TO THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE LISTS INFECTION AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE HEARTMATE II LVAS. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT UNDERWENT A ROUTINE HEART TRANSPLANT AND UPON MAKING AN INCISION DURING THE TRANSPLANT, A SMALL AMOUNT OF PUS WAS NOTED AT THE EXIT SITE. THE PATIENT WAS SUCCESSFULLY TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407047 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109739

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other