BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM- BATTERY

    MDR report key: 7601598 · Received June 14, 2018

    Report

    Report Number
    3007042319-2018-02476
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    May 13, 2018
    Report Date
    September 25, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000369
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BASED SOLELY ON THE RECEIPT OF A 3500A REPORT. SECTION F HAS BEEN UPDATED TO REFLECT THAT REPORT. F1 USER FACILITY F2 UF/IMPORTER REPORT NUMBER: 2300380000-2018-8015 F3 USER FACILITY NAME/ADDRESS: SPECTRUM HEALTH- BUTTERWORTH CAMPUS 100 MICHIGAN STREET NE GRAND RAPIDS, MI 49503 F4 CONTACT PERSON: (B)(4). F5 PHONE NUMBER: 616-486-2522 F6 DATE USER FACILITY BECAME AWARE OF EVENT: UNKNOWN F7 TYPE OF REPORT: INITIAL F8 DATE OF THIS REPORT: 06/2018 F9 APPROXIMATE AGE OF DEVICE: N/A F11 REPORT SENT TO FDA: YES F12 LOCATION WHERE EVENT OCCURRED: HOME F13 REPORT SENT TO MANUFACTURER: YES, 06/2018 F14 MANUFACTURER NAME AND ADDRESS: MFR NAME: HEARTWARE, INC. ADDL: 14400 NW 60TH AVE CITY: MIAMI STATE: FL ZIP: 33014 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 · 0

    THE BATTERY WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERY REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. ANALYSIS OF THE DATA LOG FILES REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING THE BATTERY. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERY. THE MOST LIKELY ROOT CAUSE OF THE LOSS OF POWER CAN BE ATTRIBUTED TO THE REPORTED DISCONNECTION OF BOTH POWER SOURCES FROM THE CONTROLLER, AS DESCRIBED IN THE EVENT DETAILS. AN INTERNAL INVESTIGATION EVALUATED MOMENTARY DISCONNECTIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 AND DESTINATION THERAPY 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POWER SWITCHING OCCURRED CAUSING THE POWER PORTS ON THE CONTROLLER TO FLIP TWO TIMES WHEN THE BATTERY WAS STILL FULL. THE PATIENT REPORTED TO HAVE DISCONNECTED BOTH BATTERIES AT ONCE CAUSING TWO POWER LOSSES WHILE CHECKING THE CONNECTIONS. THE PATIENT DENIED ANY SYMPTOMS. THE BATTERY WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444465 HEARTWARE VENTRICULAR ASSIST SYSTEM- BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE 00888707000369

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR (B)(4).