BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3812792 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00737
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS INPATIENT ONE WEEK OUT FROM IMPLANT. DURING THE NIGHT, THE PATIENT CUT HIS DRIVELINE WITH SCISSORS. HE DOES NOT RECOLLECT WHY HE CUT THE DRIVELINE. PUMP WAS OFF FOR APPROXIMATELY 42 MINUTES. LOW PTT 49 AT THE TIME. THE PATIENT WAS BOLUSED TO ACHIEVE PTT 200. THE PRIMARY CONTROLLER WAS EXCHANGED TO BACKUP DURING THE EVENT. THE BROWN WIRE WAS THE ONLY INTACT WIRE, THE OTHER WIRES WERE TEMPORARILY SPLICED TOGETHER BY IN-HOUSE ENGINEER. PATIENT HAS BEEN ON MILRINONE GTT SINCE IMPLANT. NO OTHER INOTROPES WERE INITIATED. THE PATIENT CURRENTLY ON BACKUP POCKET CONTROLLER AND UNGROUNDED CABLE. CENTER IS CURRENTLY WEIGHING OPTIONS OF PERC LEAD REPAIR VS. PUMP EXCHANGE VS. DEVICE TURN OFF. PSYCH AND PALLIATIVE CARE INVOLVED. THE CLINICAL SPECIALIST REPORTED THAT A SUCCESSFUL PERCUTANEOUS LEAD REPAIR WAS COMPLETED ON (B)(6) 2014. IT WAS ALSO NOTED THAT THE DAMAGE SUSTAINED TO THE SYSTEM CONTROLLER WAS DUE TO THE DAMAGED PERCUTANEOUS LEAD. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271134 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 107801 132414

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention