BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 4833646 · Received June 8, 2015

    Report

    Report Number
    3006556115-2015-00274
    Event Type
    Injury
    Date Received
    June 8, 2015
    Date of Event
    June 22, 2015
    Report Date
    May 11, 2015
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S SKIN FLAP WAS REVISED ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    FOLLOWING SKIN FLAP REVISION SURGERY, THE PATIENT REPORTEDLY COULD NOT OBTAINED LOCK WITH THE INTERNAL DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND THE DEVICE WAS ONLY ABLE TO OBTAIN LOCK WITH ONE TYPE OF PROCESSOR, HOWEVER, THE PATIENT REPORTED NO SOUND. REVISION SURGERY IS UNDER CONSIDERATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT'S EXPLANTED DEVICE REPORTEDLY CANNOT BE LOCATED BY THE HOSPITAL. SHOULD THE DEVICE BE RETURNED TO THE COMPANY, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AT THAT TIME. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS REPORTEDLY REIMPLANTED WITH ANOTHER COCHLEAR DEVICE. THE PATIENT IS DOING WELL WITH THE NEW DEVICE.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S DEVICE WAS EXPLANTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED HEADPIECE RETENTION ISSUES AND INTERMITTENT LOCK DUE TO THE PATIENT'S THICK SKIN FLAP. EXTERNAL EQUIPMENT WAS EXCHANGED AND ADDITIONAL MAGNETS WERE ADDED TO THE EXTERNAL EQUIPMENT, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SKIN FLAP SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368426 CLARION IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention