BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2010880 · Received March 3, 2011

    Report

    Report Number
    2916596-2011-00091
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 3, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETE.

    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 WHEN THE HISTORY FROM THE PT'S SYS CONTROLLER WAS DOWNLOADED SHE NOTED THE TIME CLOCK HAD RESET ON (B)(6) 2011 AT 20:38 AND THE PT'S FLOW WAS AT ZERO. THE PT STATED THAT HE WAS ON BATTERY POWER AT THE TIME AND FELT "FLUTTERING IN HIS CHEST". THE SYS CONTROLLER WAS EXCHANGED WITHOUT INCIDENT. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention