BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3012459 · Received March 15, 2013

    Report

    Report Number
    3006556115-2013-00101
    Event Type
    Injury
    Date Received
    March 15, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING PAIN AT THE IMPLANT SITE. THE SURGEON BELIEVES PAIN IS NOT DEVICE RELATED. SURGERY TO EXPLANT THE DEVICE HAS BEEN SCHEDULED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110689 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention