BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5231941 · Received November 18, 2015

    Report

    Report Number
    2916596-2015-02152
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    July 15, 2015
    Report Date
    October 21, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 6 MONTHS. THE PUMP WAS LATER EXCHANGED ON 10/19/2015 FOR AN UNRELATED EVENT AND WAS RETURNED FOR EVALUATION (REFERENCE MEDWATCH MFR REPORT #2916596-2015-02151). THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINED IN USE SUPPORTING THE PATIENT AT THE TIME OF THE EVENT AND WAS LATER EXCHANGED ON (B)(6) 2015 FOR AN UNRELATED EVENT AND WAS RETURNED FOR EVALUATION (REFERENCE MEDWATCH MFR REPORT #2916596-2015-02151). THE EVALUATION OF THE PUMP COULD NOT CONCLUSIVELY DETERMINE A CORRELATION BETWEEN THE DEVICE AND THE REPORTED DRIVELINE INFECTION. THE INSTRUCTIONS FOR USE LISTS INFECTION AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DRIVELINE INFECTION. DRAINAGE FROM THE DRIVELINE EXIT SITE WAS FIRST NOTED ON (B)(6) 2015. IN EARLY TO MID-(B)(6) THE DRAINAGE REPORTEDLY BECAME PURULENT. INFORMATION REGARDING THE TREATMENT RENDERED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762096 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention