BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7689043 · Received July 16, 2018

    Report

    Report Number
    9710014-2018-00532
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 28, 2018
    Report Date
    October 18, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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). CONCLUSION: THE DEVICE SUPPLEMENTAL SHEETS FOR RECHARGEABLE BATTERIES WERE INSPECTED UPON ARRIVAL. ACCORDING TO THE RECEIVED INFORMATION, LEAKING ELECTROLYTE WAS OBSERVED IN THE FIELD. DESPITE NO MECHANICAL ANOMALY OF THE HOUSING BEING MENTIONED IN THE SUPPLEMENTAL SHEET, A DAMAGE TO THE INTEGRITY OF THE DEVICE MIGHT STILL HAVE OCCURRED IN OTHER LOCATIONS (E.G. CRACK UNDERNEATH THE CAP). ALSO, THE OBSERVED BULGING OF THE HOUSING LIKELY INDICATES THAT THE RECHARGEABLE BATTERIES WERE NOT REFRESHED/USED FOR A LONG PERIOD OF TIME. ELECTROLYTE RESIDUALS HAVE BEEN OBSERVED ON SOME EXTERNAL SYSTEM COMPONENTS. DURING INVESTIGATIONS OF THE OTHER SYSTEM PARTS MECHANICAL DAMAGES WERE SEEN, LIKELY CAUSED BY INAPPROPRIATE HANDLING, AND OXIDATION WAS FOUND, POSSIBLY AS A CONSEQUENCE OF EXCESSIVE MOISTURE ACCUMULATION DUE TO SWEAT/HUMIDITY. HOWEVER, THESE FINDINGS DO NOT EXPLAIN THE NOTED LEAKAGES AND DID NOT CONTRIBUTE TO THEM. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015033). 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.

    Description of Event or Problem · 0

    THE USER'S MOTHER REPORTS THAT MULTIPLE RECHARGEABLE BATTERIES SWELLED AND BEGAN TO LEAK. THE USER CAME INTO CONTACT WITH THE ELECTROLYTE AND HAD BURNING SENSATIONS ON THE HAND. HOWEVER, NO SERIOUS INJURY HAS BEEN REPORTED. FURTHER INFORMATION HAS BEEN REPEATEDLY ASKED, HOWEVER NOT RECEIVED.

    Description of Event or Problem · 0

    THE USER'S MOTHER REPORTS THAT MULTIPLE RECHARGEABLE BATTERIES SWELLED AND BEGAN TO LEAK. THE USER CAME INTO CONTACT WITH THE ELECTROLYTE AND HAD BURNING SENSATIONS ON THE HAND. HOWEVER, NO SERIOUS INJURY HAS BEEN REPORTED. THE DEVICES ARE TO BE RETURNED TO US CUSTOMER SERVICE AND REPLACEMENT OF BATTERIES HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533172 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM EXTERNAL COMPONENT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH DACAPO POWERPACK 0907F154 / 0907F077

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR