BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7619149 · Received June 20, 2018

    Report

    Report Number
    9710014-2018-00440
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    May 12, 2018
    Report Date
    November 29, 2018
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015033). DUE TO IATA SHIPPING RESTRICTIONS, THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH AND VIBRANT MED-EL SUBMIT MDR REPORTS ON BEHALF OF MED-EL CORPORATION (EXEMPTION NUMBER E2015033). AS PER INFORMATION RECEIVED FROM THE FIELD THE DISPOSAL BATTERY EXPANDED IN THE BATTERY BACK TO SUCH AN EXTENT THAT IT BROKE. SO FAR NO DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THEREFORE NO ROOT CAUSE COULD BE DETERMINED FOR THE REPORTED FAILURE. TO DETERMINE A ROOT CAUSE AN INVESTIGATION OF THE CONCERNED EXTERNAL DEVICES ARE NECESSARY. REPORTEDLY THE RECIPIENT DID NOT CAME IN CONTACT WITH ELECTROLYTE AND ALSO DID NOT HAVE AN INJURY BY THE REPORTED EVENT. IN ADDITION THE CONCERNED BATTERIES ARE NOT PRODUCED OR MARKETED BY MED-EL. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE RECIPIENT REPORTED THAT WHILE WEARING THE OPUS 2 AUDIO PROCESSOR THE BATTERY PACK STARTED TO GET HOT. HE THEN REMOVED THE DEVICE FROM HIS EAR AND NOTICED THAT BATTERY PACK HAD EXPANDED. SHORTLY AFTER THAT, ONE OF THE IMPLANT POWER A675P/D6 1.45V ZINC AIR DISPOSABLE BATTERIES EXPLODED IN THE STANDARD BATTERY PACK. THE CONTENT OF THE BATTERY HAD LEAKED OUT INTO THE FRAME. THE USER DID NOT HAVE ANY CONTACT TO ANY ELECTROLYTIC FLUID. NO INJURIES HAVE THUS FAR BEEN REPORTED.

    Description of Event or Problem · 0

    THE RECIPIENT REPORTED THAT WHILE WEARING THE OPUS 2 AUDIO PROCESSOR THE BATTERY PACK STARTED TO GET HOT. HE THEN REMOVED THE DEVICE FROM HIS EAR AND NOTICED THAT BATTERY PACK HAD EXPANDED. SHORTLY AFTER THAT, ONE OF THE IMPLANT POWER A675P/D6 1.45V ZINC AIR DISPOSABLE BATTERIES EXPLODED IN THE STANDARD BATTERY PACK. THE CONTENT OF THE BATTERY HAD LEAKED OUT INTO THE FRAME. THE USER DID NOT HAVE ANY CONTACT TO ANY ELECTROLYTIC FLUID. NO INJURIES HAVE THUS FAR BEEN REPORTED. THE DEVICE WILL BE KEPT AS A BACKUP AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD, BUT NONE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464754 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM EXTERNAL COMPONENT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH ZINC AIR BATTERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR