BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3251034 · Received July 23, 2013

    Report

    Report Number
    2916596-2013-00943
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 26, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER 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. THE ATTACHED USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE INTERMACS REGISTRY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED A DEVICE TRACKING FORM VIA THEIR DEVICE TRACKING SYSTEM WHICH STATED THAT THE PT UNDERWENT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD ON(B)(6) 2013 DUE TO THROMBUS. ADDITIONAL INFO WAS RECEIVED STATING THAT THE PT HAD AN INCREASE IN HER PLATELET ALMOST IMMEDIATELY FOLLOWING IMPLANT. THE PT HAD BEEN PLACED ON COUMADIN AND ASA WITH INR TARGET OF 2.5. POST IMPLANT THE LACTATE DEHYDROGENASE (LDH) WAS AT 2000-3000 AND WAS MAINTAINED AT THAT LEVEL. THE PT WAS TO BE LISTED FOR 1A TRANSPLANT HOWEVER AN ORGAN WAS NOT AVAILABLE SO A DECISION WAS MADE TO EXCHANGE THE LVAD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342109 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124716

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention