BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3960034 · Received July 17, 2014

    Report

    Report Number
    2916596-2014-01219
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE EXPLANT DATE; HOWEVER, THE DATE WAS NOT PROVIDED. THE EXPLANT DATE HAS BEEN ESTIMATED AS THE RETURN DATE. THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVALUATION 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 HOSP REPORTED THAT THE PT HAD SUSPECTED PUMP THROMBOSIS. A LOG FILE WAS SUBMITTED TO THE MFR THAT APPEARED TO SHOW NO ADVERSE EVENTS RECORDED. THE PT REMAINED INPATIENT AND STABLE ON HEPARIN. THE PUMP WAS LATER EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417997 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 130271

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention