BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4023705 · Received August 15, 2014

    Report

    Report Number
    2916596-2014-01468
    Event Type
    Injury
    Date Received
    August 15, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED INFECTION COULD NOT BE DETERMINED. THE PATIENT WAS TREATED WITH MEDICATION FOR THE REPORTED INFECTION AND REMAINS ONGOING ON VAD SUPPORT WITH NO FURTHER EVENTS REPORTED TO THE MANUFACTURER. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IN USE BY THE PATIENT. 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). APPROX. 4 MONTHS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTERIAL DRIVELINE INFECTION. THE PATIENT WAS TREATED WITH MEDICATION. IT WAS ALSO REPORTED THAT THE CAUSE OF INFECTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490219 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911JPN 131292

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention