BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2062160 · Received March 18, 2011

    Report

    Report Number
    9710014-2011-00100
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    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 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 PT IS BILATERALLY IMPLANTED. SHE HAS A C40+ DEVICE IN HER RIGHT EAR (IMPLANTED (B)(6) 2003), AND USES CURRENTLY OPUS 2 PROCESSORS, BILATERALLY. THE PT RECEIVES EXCELLENT OPEN SET SPEECH DISCRIMINATION WITH HER RIGHT IMPLANT. THE SHOCKING SENSATIONS HAVE NEVER OCCURRED DURING NORMAL USE OUTSIDE OF THE CLINIC. UPON DISCUSSION WITH THE PT, SHE REPORTED THAT SHE HAS BEEN EXPERIENCING A BRIEF "SHOCKING" SENSATION EVERY FEW DAYS OVER THE PAST WEEK. SHE REPORTS THAT IT DOESN'T SEEM TO BE RELATED TO LOUD NOISES IN THE ENVIRONMENT. SHE ALSO REPORTED THAT THE "SHOCKING" SENSATION IS OCCURRING IN BOTH EARS, ALTHOUGH NOT AT THE SAME TIME. SHE DESCRIBES THE "SHOCKING" AS A SHARP PAIN IN HER EAR. HER EQUIPMENT APPEARED TO BE FUNCTIONING APPROPRIATELY. DURING INTEGRITY TESTING AT 230UA THE PT IMMEDIATELY BEGAN TO CRY AND COMPLAINED THAT THE SOUND WAS PAINFULLY LOUD AND 'SHOCKING'. TESTING WAS ABORTED. AFTER DISCUSSION WITH THE PT, IT WAS DETERMINED TO TRY INTEGRITY TESTING AT 80 AND 150UA. THERE WERE NO PAINFUL LOUD OR SHOCKING SENSATIONS. NO OBVIOUS FLUCTUATIONS IN SINGLE ELECTRODE RECORDINGS WERE OBSERVED AND NO HI CHANNELS EITHER.

    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 9 YR