BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 7197729 · Received January 16, 2018

    Report

    Report Number
    3004007782-2015-00005
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    June 14, 2013
    Report Date
    October 12, 2016
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: RETURNED DEVICE SP SN (B)(4) WAS TESTED (B)(6) 2013 UPON RETURN TO EMC AND PASSED ALL FFT TESTING EXCEPT FOR BATTERY VOLTAGE READING OF 2.683 V, WHICH WOULD BE LOW FOR A NEW DEVICE IN MANUFACTURING TESTING, BUT NOT DEPLETED, AND CONSISTENT WITH A DEVICE THAT HAD BEEN IMPLANTED FOR 2.6 YEARS. IN SUMMARY, THIS SP WAS REPLACED FOR BATTERY DEPLETION, BUT THE BATTERY WAS NOT ACTUALLY DEPLETED. (B)(4).

    Description of Event or Problem · 1

    ENVOY MEDICAL WAS NOTIFIED OF A SOUND PROCESSOR REPLACEMENT DUE TO BATTERY DEPLETION. THIS PARTICULAR SOUND PROCESSOR WAS IMPLANTED FOR 2.6 YEARS, WHICH IS LESS THAN THE EXPECTED WORST CASE BATTERY LIFE FOR NORMAL OPERATION OF 2.8 YEARS. HOWEVER, RETURNED DEVICE TESTING INDICATED THAT BATTERY WAS NOT ACTUALLY DEPLETED AND DEVICE PASSED FUNCTIONAL TESTING. CLINICAL HISTORY: (B)(6) 2006 - ORIGINAL IMPLANT BY DR. (B)(6), RIGHT EAR, SP SN (B)(4). (B)(6) 2006 - ACTIVATION. (B)(6) 2006 - 2 MONTH. (B)(6) 2009 - BATTERY CHANGE (SP SN (B)(4) IMPLANTED). (B)(6) 2010 - REVISION (SP (B)(4) IMPLANTED, (B)(4) EXPLANTED). (B)(6) 2013 - EARLY BATTERY CHANGE (SP (B)(4) IMPLANTED, SP (B)(4) EXPLANTED). (B)(6) 2016 - REVIEW OF HISTORY SHOWS THAT RETURNED DEVICE SP SN (B)(4) WAS TESTED (B)(6) 2013 UPON RETURN TO EMC AND PASSED ALL FFT TESTING EXCEPT FOR BATTERY VOLTAGE READING OF 2.683 V. WHILE THIS BATTERY VOLTAGE WOULD BE CONSIDERED LOW FOR A NEW PRODUCTION DEVICE, IT IS NOT BELOW THE "LOW BATTERY" THRESHOLD OF 2.4 V. THE BATTERY IS IN SUMMARY, THIS SP WAS REPLACED FOR BATTERY DEPLETION, BUT THE BATTERY WAS NOT ACTUALLY DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37969 ESTEEM ESTEEM II SOUND PROCESSOR OAF ENVOY MEDICAL 2001 EMC0003623

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention