BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1160495 · Received September 16, 2008

    Report

    Report Number
    9710014-2008-00294
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    May 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    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 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 ON JUNE 30, 2008, THAT THE PT HAD COMPLAINED ABOUT A 'PINGING' SOUND THAT FIRST OCCURRED IN 2008. WHEN THE PT MOVES HER JAW, THE SOUND MAY BE REPRODUCED. SHE HAS RECENTLY NOTICED THE SOUND MORE FREQUENTLY AND WITH AN INCREASE IN LOUDNESS. HER ABILITY TO UNDERSTAND SPEECH AND OVERALL SOUND QUALITY HAS NOT BEEN AFFECTED. TESTING OF THE IMPLANT SHOWED A SHORT CIRCUIT ON CHANNELS 6/7 AND A HI ON CHANNEL 12. THE CLINIC WERE TO CONTINUE WORKING WITH THE PT'S PROGRAM MAP IN ORDER TO REDUCE THE PT'S COMPLAINT OF 'PINGING'. NO FURTHER ACTION HAD BEEN DETERMINED AT THAT TIME. ADDITIONAL INFO REC'D BY MED-EL FOUR MONTHS LATER, STATED THAT THE PT'S AUDIOLOGIST AT THE CLINIC HAD REPORTED THAT THE PT HAD BEEN RE-IMPLANTED SIX DAYS PRIOR.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention