BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2041583 · Received March 25, 2011

    Report

    Report Number
    9710014-2011-00106
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 22, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A F/U UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPLANTED UPON REQUEST OF HER PARENTS ON (B)(6) 2011 AND REIMPLANTED WITH ANOTHER MFR DEVICE. THE IMPLANT WAS WORKING NORMALLY. CURRENTLY NO FURTHER INFO IS AVAILABLE, EXCEPT OF THAT, THE PARENTS WANT TO KEEP THE EXPLANT. THEREFORE, IF MAY NOT BE AVAILABLE FOR INVESTIGATION.

    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 4 YR Required Intervention