BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTEEM

    MDR report key: 2960859 · Received January 15, 2013

    Report

    Report Number
    3004007782-2013-00009
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    October 18, 2012
    Report Date
    January 15, 2013
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART IS A STANDARD IS-1 BIPOLAR CONNECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, DOCTOR FIRST REPORTED THAT THE DEVICE WAS INTERMITTENT WHEN THE LEADS ARE PRESSED. DOCTOR SUGGESTS PLACING ME TUBE. ON (B)(6) 2012, AFTER ME TUBE PLACEMENT DEVICE IS STILL INTERMITTENT. ON (B)(6) 2012, DEVICE WAS EXPLANTED. DOCTOR COMMENTED DUE TO THE CONDITION OF THE ANATOMY THE PATIENT WOULD RECEIVE LITTLE TO NO BENEFIT FROM THE IMPLANT. THE OSSICULAR CHAIN WAS RECONSTRUCTED WITH ENVOYCEM. DEVICE WAS EXPLANTED ON (B)(6) 2012 AND RETURNED ON (B)(6) 2012. NO PATIENT INJURY OTHER THAN REVISION SURGERY TO REPLACE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22977 ESTEEM OAF ENVOY MEDICAL 7502 EMC0004357

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention