BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2062168 · Received March 18, 2011

    Report

    Report Number
    9710014-2011-00099
    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 PULSAR DEVICE IN HER LEFT EAR (IMPLANTED (B)(6) 2007), AND USES CURRENTLY OPUS 2 PROCESSORS, BILATERALLY. ACCORDING TO CLINICIAN REPORT, SHE HAS, WITHIN THE PAST YEAR, NEEDED 4 ELECTRODES TURNED OFF IN HER LEFT EAR (ELECTRODES 8, 9, 10 AND 11) DUE TO A "SHOCKING" SENSATION REPORTED BY THE PT DURING M LEVEL MEASUREMENTS. SHE HAS REPORTEDLY NEVER HAD ANY OPEN SET SPEECH DISCRIMINATION WITH HER LEFT IMPLANT WHEREAS SHE 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 NO OBVIOUS FLUCTUATIONS IN SINGLE ELECTRODE RECORDINGS WERE OBSERVED AND NO HI CHANNELS WERE OBSERVED.

    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 9 YR