BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1234347 · Received November 18, 2008

    Report

    Report Number
    9710014-2008-00361
    Event Type
    Injury
    Date Received
    November 18, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 30, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED, AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPLANTED DEVICE WAS RECEIVED AT MED-EL CORP ON OCTOBER 29, 2008, WITHOUT PRIOR NOTIFICATION. THE DATE OF SURGERY PER THE SURGICAL REPORT WAS 2008. IT IS CURRENTLY NOT KNOWN IF A NEW DATE WAS IMPLANTED. EARLIER INFORMATION FROM 2006 AND 2007: THE PATIENT HAD HEADACHES AND REPETITIVE SOUNDS WHEN SPEECH PROCESSOR WAS BOTH ON AND OFF. HEADACHES/SOUNDS STARTED AROUND 1 MONTH AFTER SURGERY. THERE IS LITTLE REASON TO BELIEVE THE IMPLANT AS THE SOURCE OF THE PATIENT'S AILMENT. SHE REPORTS A LESSENING OF DISCOMFORT OVER TIME. THE PHYSICIAN SUSPECTS HER PAIN AS A RESULT OF SCAR TISSUE DURING REMOVAL OF THE GROUND ELECTRODE DURING REVISION SURGERY. IN 2006, THE PATIENT WOKE UP IN THE MIDDLE OF THE NIGHT, WHILE NOT WEARING THE SPEECH PROCESSOR WITH INTENSE PAIN ON THE SIDE OF HER HEAD. THIS PARTICULAR SYMPTOM OCCURRED THE ONE TIME ONLY. THE PATIENT DOES HAVE FAIRLY PERSISTENT LOW-GRADE HEADACHES AND TINNITUS-LIKE SYMPTOMS. THE CLINIC IS ENCOURAGING HER TO RECEIVE TREATMENT FOR SYMPTOMS NOT THOUGHT TO BE RELATED TO THE IMPLANT. ALL INDICATIONS OK, AND WITHIN NORMAL LIMITS FOR THE DEVICE.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention