BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3842770 · Received May 16, 2014

    Report

    Report Number
    2916596-2014-00796
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 18, 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 REMAINS IN USE SUPPORTING THE PATIENT. 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 DRIVELINE INFECTION AND A CORRELATION TO THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, THE PATIENT REMAINED ONGOING ON PUMP SUPPORT UNTIL RECEIVING A TRANSPLANT ON (B)(6) 2014. THE DEVICE WAS REPORTEDLY WORKING AS EXPECTED AT THE TIME OF THE TRANSPLANT; HOWEVER, THE PUMP WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURER'S COMPLAINT HISTORY SHOWED THAT THE PATIENT HAD A PREVIOUS COMPLAINT OF DRIVELINE INFECTION (PLEASE REFERENCE MFR REPORT # 0002916596-2013-00063). A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE INSTRUCTIONS FOR USE LISTS INFECTION AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. 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 CONTINUES TO HAVE A DRIVELINE INFECTION. THE PATIENT IS BEING TREATED WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293150 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114088

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention