BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3162282 · Received June 5, 2013

    Report

    Report Number
    2916596-2013-00714
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. THE ATTACHED USER FACILITY REPORT (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE PERFUSIONIST THAT THE PATIENT UNDERWENT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD DUE TO SUSPECTED THROMBUS. IT WAS ALSO REPORTED THAT THE POWER WAS SLIGHTLY ELEVATED. ADDITIONAL INFORMATION RECEIVED ADVISED THAT IT IS BELIEVED THAT THE PATIENT THROMBOSED DUE TO PATIENT SKIPPING ANTI-COAGULATION DOSES. THE MANUFACTURER RECEIVED USER FACILITY REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248214 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105180

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention