BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3934247 · Received June 27, 2014

    Report

    Report Number
    2916596-2014-00931
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED OT THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. THE PATIENT RECEIVED A PUMP EXCHANGE ON (B)(6) 2014, HOWEVER, THE PUMP HAS NOT YET RETURNED. 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. THE VAD COORDINATOR REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH VAD ALARMS AND PUMP STOPPAGES IN THE HISTORY. A PERCUTANEOUS LEAD REPAIR/REPLACEMENT WAS PERFORMED ON (B)(6) 2014 AND THE PATIENT WAS PLACED BACK ON A STANDARD PATIENT CABLE AND NO ALARMS OCCURRED. APPROXIMATELY 1 HOUR AFTER COMPLETING THE REPAIR, THE HOSPITAL REPORTED THAT THE SYSTEM CONTROLLER WAS ALARMING AGAIN. THE PATIENT RECEIVED A PUMP EXCHANGE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377294 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 132146

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Required Intervention