BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2883111 · Received December 21, 2012

    Report

    Report Number
    3007042319-2012-00005
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE DEVICE IS NOT GOING TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, ATTEMPTS TO UNDERSTAND WHY THE PRODUCT IS NOT BEING RETURNED ARE ON-GOING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT NOT AVAILABLE FOR RETURN.

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT OF UNKNOWN AGE AND GENDER WITH AN UNKNOWN PAST MEDICAL HISTORY WHO EXPERIENCED A HIGH POWER EVENT POST HEARTWARE LVAD IMPLANTATION. THE PATIENT WAS IMPLANTED WITH A HEARTWARE LVAD ((B)(4)) ON (B)(6) 2012. APPROXIMATELY SIX MONTHS AFTER THE IMPLANTATION, THE PATIENT'S LVAD DEMONSTRATED HIGH POWER ALARMS. THIS WAS TREATED WITH HEARTWARE LVAD EXPLANTATION AND EXCHANGE FOR ANOTHER DEVICE (PRESUMED TO BE ANOTHER HEARTWARE DEVICE BUT NOT CONFIRMED).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R