BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 15460520 · Received September 21, 2022

    Report

    Report Number
    9710014-2022-00696
    Event Type
    Malfunction
    Date Received
    September 21, 2022
    Date of Event
    September 7, 2022
    Report Date
    April 3, 2023
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    CONCLUSION: ACCORDING TO THE INFORMATION RECEIVED, THE USERS SONNET 2 AUDIO PROCESSOR SUFFERED A MALFUNCTION DUE TO A BLOWN-UP ZINC-AIR BATTERY, WHILE IT WAS IN USE. THE REPORTED ISSUE COULD BE CONFIRMED DURING DEVICE INVESTIGATION. A CELL EXPANSION IS A POSSIBLE CELL BEHAVIOR BUT CAN BE OBSERVED ONLY WITH EXTREMELY LOW PROBABILITY. IN PREVIOUS CASES SEEN BY THE SUPPLIER, THE CELL EXPANSION HAPPENED DUE TO AN ABNORMAL USE, E.G., CELL IS BEING CHARGED, REPEATED USE OF EMPTY, COMPLETELY DISCHARGED CELL OR CELL HAS NOT BEEN REMOVED FROM UNUSED HEARING AID FOR LONGER PERIOD. THE RECIPIENT DID NOT GET INJURED DUE TO THIS ISSUE. FURTHERMORE, THE DAMAGED DL-COIL CABLE IS NOT RELATED TO THE REPORTED ISSUE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    WHILE THE USER WAS WEARING THE SONNET 2 AUDIO PROCESSOR, AN EXPLOSION OF THE ZINC-AIR BATTERY WAS REPORTED. THE BATTERY WAS SWOLLEN, CRACKED AND SOOTED UP. IN ADDITION, DAMAGE OF THE COIL CABLE WAS FOUND. THEREFORE, THE USER STOPPED WEARING THE SONNET 2 AND SWITCHED TO RONDO. THE USER WILL VISIT THE CLINIC ON (B)(6) 2022.

    Description of Event or Problem · 0

    WHILE THE USER WAS WEARING THE SONNET 2 AUDIO PROCESSOR, AN EXPLOSION OF THE ZINC-AIR BATTERY WAS REPORTED. THE BATTERY WAS SWOLLEN, CRACKED AND SOOTED UP. THE SONNET 2 AND ZINC BATTERIES HAD BEEN IN USE FOR 2 DAYS. IN ADDITION, DAMAGE OF THE COIL CABLE WAS FOUND. THEREFORE, THE USER STOPPED WEARING THE SONNET 2 AND SWITCHED TO THE RONDO. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554103 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM EXTERNAL COMPONENT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH ZINC AIR BATTERIES UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Unknown