BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3022546 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00323
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS GETTING MAXIMIZED ON MEDICATION FOR POTENTIAL EXPLANT OF THE PUMP. WHEN THE PT WAS ADMITTED FOR RIGHT HEART CATHETERIZATION (RHC), THE PT COMPLAINED OF BEING SLIGHTLY SHORT OF BREATH (SOB) AND LACTATE DEHYDROGENASE (LDH) WAS SLIGHTLY ELEVATED TO 1500. THE PT'S RHC WAS NORMAL. AN (B)(6) REGISTRY REPORT WAS SUBMITTED TO THE MFR WHICH INDICATED THAT PUMP THROMBUS WAS THE CAUSE FOR PUMP EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116923 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 110659

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention