BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3233070 · Received July 11, 2013

    Report

    Report Number
    2916596-2013-00885
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 14, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED USER FACILITY REPORT # (B)(4) WHICH INDICATED THAT "ON (B)(6) 2013 PT FOUND TO HAVE BLACK URINE, JAUNDICE IN COLOR, ACUTE RENAL FAILURE, PLATELET COUNT (PLT) 9 AND ACUTE SEVERE HEMOLYSIS WITH LACTATE DEHYDROGENASE (LDH) > 3000. PT WAS TAKEN TO THE OPERATING ROOM FOR A PUMP EXCHANGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320991 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 121297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention