BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1067987 · Received June 30, 2008

    Report

    Report Number
    9710014-2008-00206
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    January 1, 2007
    Report Date
    June 20, 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 EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, THAT THE PT HAD BEEN HAVING FREQUENT REPROGRAMMING SESSIONS AS HER PERFORMANCE KEPT ON FLUCTUATING. THIS HAD BEEN OCCURRING FOR QUITE SOME TIME NOW. RECENTLY, THE FAMILY SWAPPED OUT THE EXTERNAL EQUIPMENT BUT THERE WAS NO CHANGE NOTED. THE PT HAD ALSO BEEN EXPERIENCING INTERMITTENT PAIN, BUT SHE STATED THAT THE PAIN IS NOT AROUND THE IMPLANT SITE, BUT WAS NOT ABLE TO PINPOINT EXACTLY WHERE IT IS. FOLLOWING A CHECK-UP BY MED-EL CORP IN THE SAME MONTH, THERE APPEARED TO BE NO PROBLEM WITH THE DEVICE. REPROGRAMMING HAD HELPED IN SOME OF THE PATIENTS COMPLAINTS. IN 2008, MED-EL CORP REC'D A REQUEST FROM THE CLINIC FOR AN EXPLANT KIT FOR THIS PT. THE SURGERY IS SCHEDULED TO TAKE PLACE ON THE FOLLOWING MONTH. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 8 YR