BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 3954796 · Received July 18, 2014

    Report

    Report Number
    3006556115-2014-00351
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING A SLIGHT FACIAL PARALYSIS. THE PATIENT'S EDEMA HAS LESSENED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS REPORTEDLY DOING WELL AND CONTINUES TO USE THE DEVICE. THE EDEMA WAS THE RESULT OF TISSUES GROWING UNDER THE IMPLANT.

    Additional Manufacturer Narrative · 1

    THE PT WAS HOSPITALIZED ON (B)(6) 2014.

    Additional Manufacturer Narrative · 1

    THE PT'S DEVICE WAS REPORTEDLY EXPLANTED DUE TO AN INFECTION.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, A PUNCTURE PROCEDURE WAS PREFORMED TO REDUCE THE EDEMA AT THE IMPLANT SITE. THE PATIENT'S FACIAL PARALYSIS HAS BEEN RESOLVED.

    Additional Manufacturer Narrative · 1

    THE EXTERNAL VISUAL INSPECTION REVEALED THE ELECTRODE WAS SEVERED ALONG THE LEAD PRIOR TO RECEIPT. THIS IS BELIEVED TO HAVE OCCURRED DURING REVISION SURGERY. THE DEVICE PASSED THE PHOTOGRAPHIC IMAGING INSPECTION. SYSTEM LOCK WAS VERIFIED. THE ELECTRODE CONDITION PREVENTED ONE OF THE ELECTRICAL TESTS FROM BEING PERFORMED. THE DEVICE PASSED THE ELECTRICAL AND MECHANICAL TESTS PERFORMED. THIS DEVICE WAS EXPLANTED FOR MEDICAL REASONS. THE DEVICE PASSED THE TESTS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT'S MEDICAL ISSUES HAVE REPORTEDLY RESOLVED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY PRESENTED WITH EDEMA AT THE IMPLANT SITE. THE PATIENT HAS BEEN HOSPITALIZED FOR UNKNOWN REASON AT THIS TIME. ADVANCE BIONICS IS CURRENTLY IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422153 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC I-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R