BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVA XT

    MDR report key: 7791440 · Received August 16, 2018

    Report

    Report Number
    3004209178-2018-18469
    Event Type
    Death
    Date Received
    August 16, 2018
    Date of Event
    July 21, 2018
    Report Date
    April 13, 2022
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    UDI-DI
    00643169007246
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: ADDITIONAL ANALYSIS: THE DEVICE UNDER TEST¿S (DUT) RADIO FREQUENCY MODULE (RFM) WAS EXPOSED TO 192HRS OF 85C/85% (RH) ENVIRONMENTAL TESTING AND AVERAGED A CURRENT DRAIN OF 14.5UA. TELEMETRY C WAS EXERCISED FOR 87 MINUTES OF THE 192HRS; CURRENT WAS NOMINAL FOR THIS TIME. NO POR OR CONDUCTIVE ANODIC FILAMENT (CAF) SIGNATURES WERE OBSERVED. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE WAS INCONCLUSIVE. THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO A SEVERELY DEPLETED BATTERY. THE CAUSE OF THE DEPLETION COULD NOT BE DETERMINED. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. SINCE NO CARELINK FILES COULD BE FOUND, NO SAVE TO DISK DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD, THERE IS NO WAY TO CONFIRM DEVICE CONDITION AND PROGRAMMING WHILE IMPLANTED. SINCE THERE WAS NO EVIDENCE OF A HIGH CURRENT DRAIN CONDITION, THE CAUSE OF THE DEPLETED BATTERY WAS NOT DETERMINED. NO HYBRID ANOMALIES WERE OBSERVED. BATTERY ANALYSIS DETERMINED THAT THERE WAS NO EVIDENCE OF AN INTERNAL SHORT WAS FOUND TO ACCOUNT FOR THE PREMATURE BATTERY DEPLETION. BACKLIT IMAGES OF THE ANODE FOUND UNIFORM LITHIUM-DEPLETION ACROSS THE ANODE WITH ONLY TRACE AMOUNTS OF LITHIUM REMAINING, TYPICAL OF THAT FOUND IN HIGHLY DEPLETED BATTERIES. A REVIEW OF THE MANUFACTURING DATA FOUND NO ANOMALIES NOR IRREGULARITIES NOTED DURING THE MANUFACTURING OF THIS CELL AND THE BATTERY PASSED ALL INSPECTIONS AND ELECTRICAL TESTING. HYBRID ANALYSIS WAS UNABLE TO CONFIRM A HIGH CURRENT CONDITION PRESENT WITHIN THE HYBRID. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED END OF SERVICE (EOS) AND WAS UNABLE TO BE INTERROGATED WITH SUSPECTED PREMATURE BATTERY DEPLETION. IT WAS NOTED THE DEVICE WAS NOT PACING AND THE PATIENT HAD BRADYCARDIA WITH AN INTERMITTENT SLOW HEART RATE. THE PATIENT PASSED AWAY THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630916 VIVA XT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO DTBA1D1 00643169007246

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death 4193-88 LEAD, 694765 LEAD, 5076-45 LEAD.