BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3813419 · Received March 31, 2014

    Report

    Report Number
    9710014-2014-00156
    Event Type
    Injury
    Date Received
    March 31, 2014
    Date of Event
    February 1, 2014
    Report Date
    January 31, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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 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 REPORTED GOOD PROGRESS WITH HER CI'S BILATERALLY UNTIL ABOUT 1 WEEK AGO WHEN SHE STARTED GETTING TINGLING PAIN SENSATIONS ON HER LEFT EAR DEVICE WHEN THE "S", "SH", AND "CH" SOUNDS ARE PRESENTED. SHE STATES THAT SHE GETS A HEADACHE WHEN SHE HAS TO LISTEN IN A NOISY ROOM AS THE HIGH PITCH SOUNDS ARE JUST TO UNCOMFORTABLE. SHE HAS ALSO BEEN REPORTING HEADACHES OFF AND ON FOR THE PAST WEEK SINCE SHE NOTICED THE TINGLING PAIN. AS PER THE INFO RECEIVED ON (B)(4) 2014, THE PT HAD DISCONTINUED USE OF THE DEVICE AND WAS GOING TO SCHEDULE AN APPOINTMENT TO SEE THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189966 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention