BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1182320 · Received September 30, 2008

    Report

    Report Number
    9710014-2008-00309
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    May 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B) (6) 2008, THE PATIENT BEGAN TO EXPERIENCE HEADACHES WITH A CONSTANT 'CAR HONKING'. THE HEADACHES APPEAR TO ORIGINATE IN THE CENTER OF HER HEAD, WITH THE TINNITUS IN HER IMPLANTED EAR. SHE SEEMS TO HAVE THE SYMPTOMS WITH AND WITHOUT HER PROCESSOR. WEARING THE PROCESSOR EXACERBATES HER TINNITUS. THE PATIENT IS A DEAF ADULT WHO COMMUNICATES VIA SIGN, SO IT IS DIFFICULT TO GAUGE ANY CHANGES IN HER PERFORMANCE. THE PATIENT'S PHYSICIAN REFERRED HER BACK TO AUDIOLOGY FOR FOLLOW-UP OF HER COMPLAINTS. THE AUDIOLOGY DEPT CHANGED OUT HER EXTERNALS, BUT WITH NO CHANGE. NOW IT WAS REPORTED THAT ATTEMPT WAS MADE CREATING A PROGRAM MAP WITH ALL MCL LEVELS SET TO A MINIMUM, HOWEVER, THE PATIENT IMMEDIATELY REPORTED PAIN OVER THE IMPLANT SITE WHILE WEARING THE PROCESSOR. PER THE PATIENT, SHE WORE HER PROCESSOR CONSISTENTLY UNTIL (B) (6), THEN SHE COULD NO LONGER TOLERATE WEARING IT. A CT SCAN WAS COMPLETED, EVERYTHING WAS WITHIN NORMAL LIMITS. AIDED THRESHOLDS TODAY WERE AROUND 30 DB HL WITH A SPEECH RECOGNITION THRESHOLD OF 25 DB HL. ALL CHANNELS WERE OK AND WITHIN NORMAL LIMITS. DUE TO PATIENT COMPLAINTS AND HER INABILITY TO WEAR THE PROCESSOR, THE CLINIC HAS DECIDED TO PURSUE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR