BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2883269 · Received December 21, 2012

    Report

    Report Number
    3007042319-2012-00001
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO HEARTWARE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF CONTROLLER IN RELATION TO THE REPORTED EVENT. THESE INCLUDED, BUT WERE NOT LIMITED TO, VISUAL AND FUNCTIONAL EXAMINATION, REVIEW OF CONTROLLER LOG FILES BY HEARTWARE CLINICAL FIELD ENGINEERS. BASED ON REVIEW OF ALL THE AVAILABLE INFORMATION, THE REPORTED EVENT IS CONFIRMED BASE ON THE FUNCTIONAL TEST. THE ROOT CAUSE WAS A DEFECTIVE SPEAKER. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT OF UNKNOWN AGE AND GENDER WITH AN UNKNOWN PAST MEDICAL HISTORY WHO EXPERIENCED CONTROLLER ALARM SOUND ISSUES. THE PATIENT WAS IMPLANTED WITH A HEARTWARE LVAD ON (B)(6) 2010. APPROXIMATELY TWENTY-NINE MONTHS AFTER THE IMPLANTATION, THE PATIENT'S CONTROLLER (CON003742) WAS REPORTED TO NOT BE PRODUCING ANY SOUND. THIS EVENT WAS TREATED WITH AN ELECTIVE CONTROLLER EXCHANGE. THERE WAS NO REPORTED PATIENT INJURY AND THE PRODUCT IS TO BE RETURNED FOR EVALUATION. INVESTIGATION OF THIS EVENT IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1