BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 6770018 · Received August 7, 2017

    Report

    Report Number
    9710014-2017-00650
    Event Type
    Injury
    Date Received
    August 7, 2017
    Date of Event
    June 11, 2017
    Report Date
    October 25, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO (B)(4) WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE INVESTIGATIONS OF THE RECEIVED PARTS DID NOT REVEAL ANY DEVICE DEFECT OR PROBLEM WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED. THIS FINDING WAS EXPECTED, BECAUSE ACCORDING TO THE RECIPIENT REPORT THE DEVICE WAS EXPLANTED FOR MEDICAL REASONS, NAMELY POOR BENEFIT DUE TO COCHLEAR OSSIFICATION. THE OSSIFICATION, CAUSED BY MENINGITIS IN EARLY AGE, COMBINED WITH A REPORTEDLY COMPLICATED COCHLEA, EXPLAINS THE POOR OUTCOMES AND THE NON-AUDITORY STIMULATION WITH THE COCHLEAR IMPLANT AND THE CHOICE OF IMPLANTING AN ABI DEVICE, WHICH IS GIVING BENEFIT. IN SITU MEASUREMENTS SHOWED HI AND SC CHANNELS, HOWEVER THE ELECTRODES WERE NOT RECEIVED WITH THE DEVICE, THEREFORE A FAILURE COULD NOT BE CONFIRMED. DURING INVESTIGATION THE DEVICE OPERATES WITHIN SPECIFICATION. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A COMPRESSED ARRAY IN 2009 IN (B)(6) DUE TO SEVERE OSSIFICATION. IN 2016 PERFORMANCE WITH THE DEVICE WORSENED. PER EXPLANTATION REPORT, THE PATIENT HAD NON-AUDITORY STIMULATION. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2017 WITH A SYNCHRONY ABI.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A COMPRESSED ARRAY IN 2009 IN GERMANY DUE TO SEVERE OSSIFICATION. CURRENTLY, THE PATIENT IS BEING TREATED IN ISRAEL. IN 2016 PERFORMANCE WITH THE DEVICE WORSENED. THE PATIENT WAS RE-IMPLANTED ON (B)(6)2017 WITH A SYNCHRONY ABI (AUDITORY BRAINSTEM IMPLANT) AND IS DOING WELL. PER EXPLANTATION REPORT, THE PATIENT HAD NON-AUDITORY STIMULATION WITH THE OLD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552825 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention