BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2894286 · Received December 27, 2012

    Report

    Report Number
    2916596-2012-01272
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 5, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 INFORMATION 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT BECAME DIAPHORETIC, NAUSEATED AND HEMODYNAMICALLY UNSTABLE AND WAS ADMITTED TO THE ICU. A NEUROLOGIST WAS CONSULTED AND STATED THAT THE PT EXPERIENCED A TRANSIENT ISCHEMIC ATTACK (TIA). THE PT WAS ON ASPIRIN (ASA), COUMADIN AND PLAVIX AT THE TIME, DUE TO POWER ELEVATIONS THE PT HAD BEEN EXPERIENCING THE PREVIOUS WEEK. HEPARIN GTT WAS ADMINISTERED. IT WAS ALSO REPORTED THAT THE PT WAS HAVING SLURRED SPEECH, DROOLING AND RIGHT UPPER ARM WEAKNESS. POSITIVE FACTOR 8 WAS ADMINISTERED. A DECISION WAS MADE TO EXCHANGE THE LVAD PUMP WITH ANOTHER LVAD PUMP ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 119637

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention