BEUDAMED
    FDA Adverse Event Other Summary report: N

    ESTEEM SYSTEM

    MDR report key: 2912894 · Received December 3, 2012

    Report

    Report Number
    3004007782-2012-00006
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    February 24, 2012
    Report Date
    November 29, 2012
    Manufacturer
    ENVOY MEDICAL
    Product Code
    OAF
    PMA / PMN Number
    P090018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RECONSTRUCTED. MAY HAVE ANOTHER OPERATION. NOTE: LATE FILING OF REPORT AS PER DISCUSSION WITH (B)(4), 2012.

    Description of Event or Problem · 1

    EXPLANT OF SOUND PROCESSOR TO SUPPORT TREATMENT OF INFECTION. INITIAL IMPLANT (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTEEM SYSTEM OAF ENVOY MEDICAL 2001 EMC0003754

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention