BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3181308 · Received June 12, 2013

    Report

    Report Number
    2916596-2013-00760
    Event Type
    Injury
    Date Received
    June 12, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS SUCCESSFULLY EXCHANGED AND THE PT REMAINS ONGOING WITHOUT ANY FURTHER ISSUE REPORTED. (B)(4). THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR'S ASSISTANT REPORTED THAT THE PT DEVELOPED ACUTE HEART FAILURE SYMPTOMS INDICATIVE OF A THROMBUS AND THE PUMP WAS EXCHANGED EMERGENTLY. THE MFR ALSO RECEIVED A USER FACILITY REPORT FROM THE (B)(6) REGISTRY WHICH STATED "PT ADMITTED WITH DARK URINE, LDH 10500, PF HGB 52, ALT 4312, AST 9115, CREATININE 2.7, INR 12. PT STATED THAT HE HAS HAD DARK TEA COLORED URINE FOR 2 WEEKS PRIOR TO ADMISSION. SUSPECT PUMP THROMBOSIS/PUMP FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266079 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122810

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention