BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 4432372 · Received January 16, 2015

    Report

    Report Number
    3004007782-2015-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    December 15, 2014
    Report Date
    December 17, 2014
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: TEST RESULTS FROM JULY 2014 (DURING DEVICE MANUFACTURE) WERE REVIEWED. SOUND PROCESSOR (SN (B)(4)) PASSED ALL FULL-FUNCTIONAL TESTING. THE SOUND PROCESSOR (SN (B)(4)) WAS EVALUATED UPON RECEIPT AT ENVOY MEDICAL. THE RETURNED SP PASSED ALL FULL-FUNCTIONAL TESTING. THE LEAD BORES, CONNECTOR BLOCKS, AND SPRING CONTACTS OF THE RETURNED SP WERE EXAMINED, BOTH WITH THE UNAIDED EYE AND UNDER MAGNIFICATION. NO DAMAGE WAS VISIBLE, NO WERE ANY ABNORMALITIES OBSERVED. A FUNCTIONAL FIT-CHECK WITH TEST LEADS ALSO REVEALED NO ABNORMALITIES RELATED TO LEAD INSERTION.

    Description of Event or Problem · 1

    ON (B)(6) 2014 - ENVOY MEDICAL WAS NOTIFIED OF A REVISION SURGERY DUE TO A NON-FUNCTIONING DEVICE. EVENT TIMELINE: ON (B)(6) 2010 - ORIGINAL IMPLANT SURGERY (RIGHT EAR). ON (B)(6) 2014 - SOUND PROCESSOR (SP) REPLACED DUE TO NORMAL BATTERY DEPLETION. DURING THE PROCEDURE, PATIENT WAS KEPT FULLY ALERT. PATIENT RESPONDED TO SOUND FROM THE NEW SP (SN (B)(4)) WHEN IT WAS PLUGGED INTO THE SENSOR AND DRIVER LEADS (PRIOR TO PLACING SP INTO PATIENT'S SUBCUTANEOUS POCKET). ON (B)(6) 2014 - PATIENT COMPLAINED OF A NON-FUNCTIONING DEVICE AND RETURNED TO THE SURGEON WHO PERFORMED THE EARLIER BATTERY REPLACEMENT. DIAGNOSTICS WERE PERFORMED WHICH INDICATED THE DRIVER LEAD HAD RETRACTED FROM THIS FUNCTIONAL POSITION IN THE HEADER. SURGEON THEN OPENED THE INCISION AND CONFIRMED THE RETRACTED DRIVER LEAD BY PUSHING THE RETRACTED LEAD INTO THE SP HEADER (SN (B)(4)) AT WHICH POINT THE PATIENT SIMULTANEOUSLY NOTED FULL VOLUME FROM THE DEVICE. SP 212606 WAS THEN UNPLUGGED AND REPLACED WITH A NEW SP. ON (B)(6) 2014 - DEVICE WAS RECEIVED AT ENVOY MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40668 ESTEEM OAF ENVOY MEDICAL 2001 EMC0005537

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention PATIENT HAS SECOND ESTEEM IMPLANT IN LEFT EAR.