BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 653139 · Received December 16, 2005

    Report

    Report Number
    2029203-2005-00531
    Event Type
    Injury
    Date Received
    December 16, 2005
    Date of Event
    November 17, 2005
    Report Date
    December 16, 2005
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED HEADACHES AND SOUND PERCEPTION PROBLEMS. IN 2005, THE PT WAS SEEN BY A CO REP FOR DEVICE EVAL. TESTING CONFIRMED THAT THE PT'S DEVICE WAS FUNCTIONING WITHIN NORMAL LIMITS. HOWEVER, THE DECISION WAS MADE TO EXPLANT THE PT'S C1 DEVICE.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED HEADACHES AND SOUND PERCEPTION PROBLEMS. IN NOV-2005, THE PT WAS SEEN BY A COMPANY REPRESENTATIVE FOR DEVICE EVALUATION. TESTING CONFIRMED THAT THE PATIENT'S DEVICE WAS FUNCTIONING WITHIN NORMAL LIMITS. HOWEVER, THE DECISION WAS MADE TO EXPLANT THE PATIENT'S C1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. AB-5100H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention