BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6157493 · Received December 9, 2016

    Report

    Report Number
    9710014-2016-00858
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Report Date
    April 27, 2018
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AS PER THE INFORMATION RECEIVED, THE DACAPO POWERPACK WAS FOUND WITH LEAKING ELECTROLYTE; HOWEVER, NEITHER PATIENT CONTACT TO BATTERY CHEMISTRY NOR ANY INJURIES WERE REPORTED. NO ROOT CAUSE FOR THE MALFUNCTION COULD BE DETERMINED AS THE DEVICE HAS NOT BEEN RECEIVED FOR FAILURE INVESTIGATION. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE RETURNED DEVICE SUPPLEMENTAL SHEET FOR RECHARGEABLE BATTERIES WAS INSPECTED UPON ARRIVAL. ACCORDING TO THE RECEIVED INFORMATION, LEAKING ELECTROLYTE WAS OBSERVED. THE DAMAGE TO THE BATTERY HOUSING WAS CLEARLY THE REASON FOR THE MALFUNCTION OF THE DEVICE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE SUPPLEMENTAL SHEET FOR RECHARGEABLE BATTERIES WAS INSPECTED UPON ARRIVAL. ACCORDING TO THE RECEIVED INFORMATION, LEAKING ELECTROLYTE WAS OBSERVED. THE DAMAGE TO THE BATTERY HOUSING WAS CLEARLY THE REASON FOR THE MALFUNCTION OF THE DEVICE. ADDITIONAL INFORMATION: TWO MORE SUPPLEMENTAL SHEETS FOR DACAPO POWERPACKS (SN (B)(4) SN (B)(4)) WERE ADDED TO THIS RECORD AND INVESTIGATED UPON ARRIVAL. ALL THREE DEVICES SHOW THE SAME FAILURE. THEREFORE, THE ABOVE MENTIONED RESULTS DO STILL APPLY.

    Description of Event or Problem · 1

    AN INSPECTION FOR THE DACAPO POWERPACK HAS BEEN REQUESTED BECAUSE IT WASN'T WORKING WELL. ELECTROLYTE LEAKAGE HAS BEEN FOUND AT THE INSPECTION.

    Description of Event or Problem · 1

    AN INSPECTION OF THE DACAPO POWERPACK WAS REQUESTED BECAUSE IT WASN'T WORKING WELL. ELECTROLYTE LEAKAGE WAS FOUND DURING THE INSPECTION. THE DACAPO POWERPACK WILL NOT BE RETURNED TO HQ (B)(4).

    Description of Event or Problem · 1

    AN INSPECTION OF THE DACAPO POWERPACK WAS REQUESTED BECAUSE IT WASN'T WORKING WELL. ELECTROLYTE LEAKAGE WAS FOUND DURING THE INSPECTION. THE DACAPO POWER PACK WILL NOT BE RETURNED TO (B)(4)

    Description of Event or Problem · 1

    AN INSPECTION FOR THE DACAPO POWERPACK WAS REQUESTED BECAUSE IT WASN'T WORKING PROPERLY. ELECTROLYTE LEAKAGE WAS FOUND DURING THE INSPECTION. THERE WAS NO USER CONTACT WITH ELECTROLYTE FLUID AND NO INJURY SUSTAINED. ADDITIONAL TWO DEVICES HAVE BEEN CONFIRMED TO HAVE LEAKED. THE DACAPO POWER PACKS HAVE NOT BEEN RETURNED TO HQ (B)(4); HOWEVER DEVICE SUPPLEMENTAL SHEETS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813219 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM EXTERNAL COMPONENT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH DACAPO POWERPACK 1308C083

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR