BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4023440 · Received August 14, 2014

    Report

    Report Number
    2916596-2014-01424
    Event Type
    Injury
    Date Received
    August 14, 2014
    Date of Event
    June 15, 2014
    Report Date
    July 17, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IN USE BY THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. A DIRECT RELATIONSHIP BETWEEN THE LVAD AND THE REPORTED EVENT COULD NOT BE DETERMINED AS THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. 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

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT HAS BACTEREMIA AND IS CURRENTLY ON ANTIBIOTICS (RIFAMPIN) DUE TO CONTINUING ISSUES WITH INFECTION. PATIENT IS CURRENTLY DISCHARGED AND BEING WORKED UP FOR GASTRIC BYPASS SO AS TO BE LISTED FOR TRANSPLANT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 1 MONTH POST-IMPLANT, IT WAS REPORTED THAT THE PT WAS READMITTED INTO THE HOSPITAL DUE TO FEVER AND PURULENT DRAINAGE FROM THE SUBCOSTAL INCISION SITE FROM THE RECENT PUMP EXCHANGE (REFERENCE MFR #0002916596-2014-00838). THE PT WAS PLACED ON IV ANTIBIOTICS AND DISCHARGED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486617 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 139212

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention