BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR 3G BTE PROCESSOR

    MDR report key: 495475 · Received November 5, 2003

    Report

    Report Number
    MW1030097
    Event Type
    Injury
    Date Received
    November 5, 2003
    Date of Event
    February 11, 2003
    Report Date
    November 5, 2003
    Manufacturer
    COCHLEAR CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS A NUCLEUS COCHLEAR IMPLANT, IMPLANTED WITH AN N24-CONTOUR AND WHEN PUTTING THE 3G BTE ON PT EXPERIENCED A SHOCK SENSATION AND IMMEDIATE INTENSE PAIN INSIDE THEIR EAR, BEHIND THE EARDRUM. PT SNATCHED THE EXTERNAL DEVICE OFF AND THOUGHT THAT THEIR DAMP HAIR HAD CAUSED A SHORT AS THE BATTERY COVER HAD FALLEN OFF. PT TRIED REPLACING THE PROCESSOR AND PT GOT NO SOUND AT ALL. PT THOUGHT THEY HAD WIPED OUT THE COMPUTER MAPS SO PT GOT OUT THEIR SPRINT BODY- WORN PROCESSOR AND PT GOT NO SOUND WITH IT EITHER. TESTS THE NEXT DAY SHOWED NO HEARING BUT THE PROCESSORS TO BE FUNCTIONAL. EXTENSIVE TESTING LATER IN THE SPRING AND IN AUGUST SHOW THE DEVICE TO BE FUNCTIONAL BUT PT HAS NO SOUND OTHER THAN STATIC THROUGH THE PROCESSORS REPORTER WAS TOLD BY COCHLEAR ENGINEERS THIS IS CALLED A SWITCH IN TRANSIENT AND HAS HAPPENED BEFORE BUT NOT WITH THESE CONSEQUENCES. THE DAMP HAIR HAD NOTHING TO DO WITH THIS AT ALL. REPORTER WAS ALSO TOLD THAT SWITCHING SURGES HAD INDEED OCCURRED IN THE PAST WITH THE N-22 BUT THE COIL WAS CHANGED AND THE PROBLEM ELIMINATED. MIGHT PT BE THE FIRST TO HAVE THIS PROBLEM WITH THE 3G SINCE IT HAD ONLY RECEIVED FDA APPROVAL IN THE SPRING OF 2002 AND PT GOT THEIRS 4 MONTHS LATER? HAS COCHLEAR REPORTED ANY OF THESE OTHER SHOCKS, TRANSIENTS/SURGES? PT WOULD GREATLY APPRECIATE ANY INFO FDA HAS AS PT WAS DEAF AND HAS NO ALTERNATIVES. THIS MAY HAVE NEVER CAUSED THESE PROBLEMS BEFORE BUT IT IS PT'S DESIRE THAT IT NEVER HAPPEN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COCHLEAR 3G BTE PROCESSOR COCHLEAR IMPLANT SMALL PROCESSOR MCM COCHLEAR CORPORATION NUCLEUS ESPRIT 3G *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability