BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4782160 · Received May 19, 2015

    Report

    Report Number
    3007042319-2015-00919
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    May 12, 2014
    Report Date
    April 20, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. NEUROLOGICAL IS A KNOWN POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE FURTHER PROVIDES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES. BASED ON THIS PATIENT'S HISTORY OF RECURRENT NEUROLOGICAL DYSFUNCTIONS, IT APPEARS THAT CLINICAL AND/OR PHARMACOLOGICAL FACTORS AND PATIENT COMORBIDITIES MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE LACK OF INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE EVENT OR THE RELATIONSHIP TO THE DEVICE OR TREATMENT; HOWEVER, THERE WAS NO REPORT OF ANY DEVICE PERFORMANCE ISSUES. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OR THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA THE INTERMACS REGISTRY THAT THIS PATIENT HAD A SERIOUS ADVERSE EVENT INDICATED AS "NEUROLOGICAL DYSFUNCTION" AND "REHOSPITALIZATION" ON (B)(6) 2014. NO FURTHER INFORMATION REGARDING THE EVENTS WAS PROVIDED; HOWEVER, IT IS KNOWN THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AT AN UNKNOWN DATE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326995 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R