BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2864402 · Received December 6, 2012

    Report

    Report Number
    2916596-2012-01190
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 11, 2012
    Report Date
    November 11, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION 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). THE VAD COORDINATOR REPORTED THAT THE PATIENT IS IN THE INTENSIVE CARE UNIT (ICU) WHERE INOTROPES WERE INITIATED, THE PATIENT HAS BACK PAIN, IS ANURIC WITH SYMPTOMS OF NAUSEA/VOMITING. RED HEART ALARMS OCCUR ONLY WHEN THE PATIENT IS TETHERED TO THE POWER MODULE. IT WAS ALSO NOTED THAT THE PATIENT RECENTLY DROPPED HER POWER MODULE, RESULTING IN HER RECEIVING A TEMPORARY LOANER. ALSO NOTED WAS THAT THE PATIENT HAS A CHRONIC PERCUTANEOUS LEAD INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 94597

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening