BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 12652273 · Received October 18, 2021

    Report

    Report Number
    3007042319-2021-06642
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    May 20, 2020
    Report Date
    November 16, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS A DUPLICATE OF FDA REPORT NUMBER 3007042319-2020-03183 CORRECTED SECTIONS: A.1) PT IDENTIFIER FROM UNK TO (B)(6), DATE OF BIRTH: FROM BLANK TO (B)(6) 1950, D.4) SERIAL # FROM (B)(6), UDI#:FROM (B)(4), H.4) DEVICE MFG DATE: FROM 2018-05-08 TO 2018-05-31. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UF/IMPORTER REPORT NUMBER: (B)(4). USER FACILITY NAME/ADDRESS, CONTACT PERSON, PHONE NUMBER: (B)(6). DATE USER FACILITY BECAME AWARE OF THE EVENT: N/A. TYPE OF REPORT: INITIAL. DATE OF THIS REPORT: XX-SEP-2021. APPROXIMATE AGE OF DEVICE: 2 YEARS. EVENT PROBLEM CODES: N/A. REPORT SENT TO FDA: N/A. LOCATION WHERE EVENT OCCURRED: HOME. REPORT SENT TO MANUFACTURER: YES, XX-SEP-2021. MANUFACTURER NAME AND ADDRESS: HEARTWARE, INC, (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH ANEMIA AND MELENA AFTER EXPERIENCING THREE GASTROINTESTINAL BLEEDING EVENTS. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.3 AND HEMOGLOBIN WAS 7.2 DESPITE AN INR GOAL OF 2.0-2.5 AND A LACK OF ASPIRIN THERAPY. THE PATIENT WAS TREATED WITH SIX UNITS OF PACKED RED BLOOD CELLS. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED, AND NO SOURCE OF BLEEDING WAS IDENTIFIED. A COLONOSCOPY REVEALED BLOOD THROUGHOUT THE ENTIRE COLON. ANTICOAGULATION BRIDGING WAS PREFORMED PRIOR TO THE PATIENT BEING DISCHARGED. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546007 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Life Threatening| H| R