BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 19264400 · Received May 7, 2024

    Report

    Report Number
    3007042319-2024-03385
    Event Type
    Death
    Date Received
    May 7, 2024
    Date of Event
    December 16, 2022
    Report Date
    May 7, 2024
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/57 YEARS OLD. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE DATE OF DEATH IS NOT AVAILABLE AT THE TIME OF THIS REPORT AS THERE IS NO INDICATION OF SPECIFIC SERIAL NUMBER/PATIENT INFORMATION. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: ASSOCIATION BETWEEN AMIODARONE AND VENTRICULAR TACHYCARDIA AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANT: A SINGL E-CENTER EXPERIENCE. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2023. 66:1265¿1267. DOI: 10.1007/S10840-022-01401-Y MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE ASSOCIATION BETWEEN AMIODARONE AND VENTRICULAR TACHYCARDIA (VT) AFTER LEFT VENTRICULAR ASSIST DEVICE (VAD) IMPLANT. ALL PATIENTS EXPERIENCED SUSTAINED VENTRICULAR ARRHYTHMIAS AFTER DISCHARGE FROM THE HOSPITAL POST VAD IMPLANT. PATIENTS WERE IN TWO COHORTS, THOSE ON AMIODARONE AND THOSE WHO WERE NOT (SOME STOPPED AMIODARONE DUE TO CLINICAL STABILITY, PULMONARY TOXICITY, THYROID TOXICITY, HEPATOTOXICITY, AND IDIOSYNCRATIC ALLERGIC REACTION. THE AUTHORS DESCRIBED PATIENT DEATHS; HOWEVER, THE CAUSES OF DEATH WERE UNKNOWN. THERE WERE PATIENTS WHO UNDERWENT ABLATIONS FOR VT. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671967 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Death