BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4121257 · Received September 23, 2014

    Report

    Report Number
    2916596-2014-01676
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORD THAT THE PT'S LACTATE DEHYDROGENASE LEVEL ON (B)(6) 2014 WAS 1147 UL, WHICH WAS UP FROM THE 300'S. THE PT WAS ADMITTED FOR EVAL. THE PT WAS LISTED FOR HEART TRANSPLANT AND A HEART BECAME AVAILABLE ON (B)(6) 2014. THE LVAD WAS EXPLANTED DURING TRANSPLANT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591206 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 139212

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention NA.