BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 7695194 · Received July 17, 2018

    Report

    Report Number
    3007042319-2018-03075
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 25, 2018
    Report Date
    November 26, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION A1. PRODUCT EVENT SUMMARY: ONE OF THE REPORTED BATTERIES ((B)(4)) WAS NOT AVAILABLE FOR EVALUATION; WHILE THE REMAINING EIGHT BATTERIES WERE RETURNED. FAILURE ANALYSIS REVEALED THAT THE RETURNED DEVICES PASSED FUNCTIONAL TESTING AND VISUAL INSPECTION. THE BATTERIES WERE ABLE TO ADEQUATELY CONNECT TO A CONTROLLER. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO AN INTERMITTENT CONNECTION BETWEEN THE BATTERIES AND CONTROLLER. ADDITIONAL PRODUCTS: BATTERY, (B)(4) D10: YES, RETURN DATE: 2018-07-12 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY, (B)(4) D10: YES, RETURN DATE: 2018-07-12 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY, (B)(4) D10: YES, RETURN DATE: 2018-07-12 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY, (B)(4) D10: YES, RETURN DATE: 2018-07-12 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY, (B)(4) D10: NO H6 FDA METHOD CODE(S): 4114 H6 FDA RESULTS CODE(S): 3221 H6 FDA CONCLUSION CODE(S): 67 BATTERY, (B)(4) D10: YES, RETURN DATE: 2018-07-12 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY, (B)(4) D10: YES, RETURN DATE: 2018-07-12 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY, (B)(4) D10: YES, RETURN DATE: 2018-07-12 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67. 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

    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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31 UDI #: (B)(4) MFG DATE: 2016-07-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31 UDI #: (B)(4) MFG DATE: 2016-07-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31 UDI #: (B)(4) MFG DATE: 2016-07-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31 UDI #: (B)(4) MFG DATE: 2016-07-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31 UDI #: (B)(4) MFG DATE: 2016-07-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31 UDI #: (B)(4) MFG DATE: 2016-07-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-07-31 UDI #: (B)(4) MFG DATE: 2016-07-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-11-30 UDI #: (B)(4) MFG DATE: 2016-11-30 (B)(4). 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 HAD DIFFICULTY CONNECTING THEIR BATTERIES TO THE CONTROLLER. THE DEVICES ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535444 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR MCS UNKNOWN VAD