BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3954845 · Received July 17, 2014

    Report

    Report Number
    3006556115-2014-00344
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    March 27, 2015
    Report Date
    June 26, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT REVISION SURGERY TO THIN THE SKIN FLAP AND REPLACE THE INTERNAL MAGNET ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED MAGNET PASSED THE VISUAL INSPECTION. THE EXPLANTED MAGNET PASSED THE GUASS MEASUREMENT. THE MAGNET PASSED THE TESTS PERFORMED. NO CORRECTIVE ACTION IS INDICATED. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PT'S SCAB REPORTEDLY APPEARS TO BE AN UNDISSOLVED STITCH.

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PATIENT'S IMPLANT INCISION SITE HAS HEALED AND THE PATIENT IS REPORTEDLY DOING WELL. THE PATIENT REMAINS IMPLANTED. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTERNAL MAGNET WAS RECEIVED BY THE COMPANY ON (B)(6) 2015. THE PATIENT'S DEVICE HAS BEEN ACTIVATED AND THE PATIENT DOES NOT REQUIRE ADDITIONAL EXTERNAL MAGNET TO OBTAIN HEADPIECE RETENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF LOCK AND INTERMITTENCY ISSUES. THE DOCTOR CONFIRMED THAT THE PATIENT'S THINK SKIN FLAP IS THE ISSUE. ADDITIONAL MAGNETS WERE USED TO ACHIEVE LOCK; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. SKIN FLAP REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420042 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention