BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II POWER MODULE

    MDR report key: 2502341 · Received February 21, 2012

    Report

    Report Number
    2916596-2012-00155
    Event Type
    Malfunction
    Date Received
    February 21, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED A RED HEART ALARM. THE FAMILY NOTICED THAT THE POWER MODULE¿S POWER SYMBOL WAS AMBER INSTEAD OF GREEN IN COLOR. THE PT DID NOT REPORT A LOSS OF ELECTRICITY TO THE HOME DURING THE EVENT. THE LOG FILE SHOWED A PUMP STOPPAGE, THOUGH THE PT WAS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II POWER MODULE DSQ: POWER MODULE DSQ THORATEC CORP. 1340 89783

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention