BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESTEEM

    MDR report key: 7097469 · Received December 7, 2017

    Report

    Report Number
    3004007782-2017-00001
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    December 13, 2016
    Report Date
    January 17, 2017
    Manufacturer
    ENVOY MEDICAL CORP.
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PASSED ALL MANUFACTURING ACCEPTANCE TESTING AND QUALITY INSPECTION.

    Description of Event or Problem · 1

    REPORT CAME IN TO ENVOY COMPLAINTS THAT A DEVICE HAD NO DRIVER FUNCTIONALITY AT ACTIVATION. ON (B)(6) 2016 - PATIENT WAS IMPLANTED WITH THE ESTEEM SYSTEM. BOTH THE SENSOR AND DRIVER WERE TESTED DURING IMPLANT AND WERE FOUND TO BE PERFORMING ACCEPTABLY. THE SOUND PROCESSOR (SP) WAS TESTED AND FOUND TO BE OPERATING ACCEPTABLY. THE DEVICE WAS DEACTIVATED AND THE PATIENT WAS CLOSED UP. ON (B)(6) 2016 - PATIENT CAME IN FOR DEVICE ACTIVATION. UPON ACTIVATION, IT WAS DISCOVERED THAT THE SYSTEM WAS NOT FUNCTIONING AND TESTING INDICATED THAT THE DRIVER WAS NOT PROVIDING ANY SIGNAL TO THE SOUND PROCESSOR A CT WAS PLANNED TO INVESTIGATE WHETHER THE CAUSE WAS DUE TO THE DRIVER LEAD BACKING OUT OF THE SP, OR PERHAPS THE DRIVER LEAD HAS LOST CONTACT WITH THE ANATOMY. ON (B)(6) 2017 - TRANSMASTOID REVISION WAS PERFORMED. PER THE REVISION REPORT "PRE-SURGICAL DATA SUGGESTS AN ISSUE WITH THE DRIVER, DRIVER LEAD, OR THE SOUND PROCESSOR." THEREFORE, A "STEP BY STEP APPROACH TO ISOLATE EACH COMPONENT TO EVALUATE WHERE THE PROBLEM ORIGINATES, AND ANY OTHER VARIABLES THAT MAY BE HINDERING FUNCTIONALITY" WAS PLANNED PREOPERATIVELY. UPON TESTING, NO ISSUES WITH THE DRIVER WERE FOUND. THE DRIVER PASSED ALL CAPACITANCE TESTING. HOWEVER, SENSOR TESTING INDICATED LOW CAPACITANCE (APPROXIMATELY 50%). THE SENSOR WAS REPLACED DUE TO THIS LOW CAPACITANCE TEST. THERE WERE PROBLEMS NOTED WITH THE SOUND PROCESSOR (SP), BUT THE SP WAS REPLACED AS A BEST PRACTICE FOR ANY TRANSMASTOID REVISION SURGERY. DEVICE RETURNED TO ENVOY ON 6/13/17. RETURNED SP PASSES TESTING. SENSOR PZT IS CRACKED, BUT CRACKED PZT DOES NOT ACCOUNT FOR REPORTED SYMPTOM OF "NO FUNCTIONALITY". TESTING WAS CONDUCTED TO TRY AND REPLICATE THE SYMPTOMS BY SWAPPING LEADS IN SP, BUT THIS DID NOT REPRODUCE THE REPORTED SYMPTOM, EVEN WHEN USING A SENSOR WITH A CRACKED PZT. NO OTHER PROCEDURAL ISSUES COULD BE IMAGINED TO ACCOUNT FOR THE REPORTED ISSUE. ISSUE COULD NOT BE REPRODUCED IN THE LABORATORY. ON (B)(6) 2017 - PATIENT WAS REACTIVATED AND SYSTEM IS WORKING WELL. PATIENT IS HAPPY WITH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875178 ESTEEM ESTEEM II DRIVER OAF ENVOY MEDICAL CORP. 7510 EMC0005688

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention