BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7876250 · Received September 14, 2018

    Report

    Report Number
    9710014-2018-00742
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 29, 2018
    Report Date
    February 4, 2019
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737094041
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015033). THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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). CONCLUSIONS: DEVICE INVESTIGATIONS DID NOT REVEAL ANY DEVICE DEFECT OR PROBLEM WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED. MECHANICAL DAMAGES LIKELY DUE TO HANDLING WERE NOTED ON THE ACTIVE ELECTRODE, WHICH GO IN LINE WITH THE DAMAGE OF THE ACTIVE ELECTRODE ARRAY FOLLOWING RE-INSERTION ATTEMPT AS MENTIONED IN THE EXPLANT REPORT. AS PER RECEIVED INFORMATION, THE DEVICE WAS EXPLANTED FOR MEDICAL REASONS, NAMELY THE HOUSING EXTRUDED THROUGH THE SKIN DUE TO FIBROTIC CAPSULE FORMATION AND EDEMATOUS TISSUE WITH POST AURICULAR FISTULA. NO AVAILABLE INFORMATION POINTS TO THE DEVICE HAVING CONTRIBUTED TO THE OBSERVED SYMPTOMS. IN ADDITION CHRONIC PAIN WAS REPORTED AT THE IMPLANT SITE, WHICH WAS LIKELY RELATED TO THE PRESENCE OF THE FISTULA. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    APPROXIMATELY IN MID-(B)(6) 2018 THE RECIPIENT NOTICED THE RECEIVER STIMULATOR WAS STARTING TO EXTRUDE POST AURICULARLY AND CONTINUED TO MIGRATE OUT THROUGH A POST AURICULAR FISTULA. THE EXTERNAL PROCESSOR COULD NOT BE WORN DUE TO EXTRUSION. THE RECIPIENT WAS EXPLANTED. NO NEW DEVICE WAS PLACED. PER DEVICE EXPLANTATION REPORT, THE RECIPIENT HAD CHRONIC PAIN IN THE REGION OF THE STIMULATOR AND A SLOW INCREASE IN SIZE OF A PSEUDO-CAPSULE. THERE WAS A CONSIDERABLE FIBROTIC CAPSULE AND EDEMATOUS TISSUE IN CONTACT WITH THE STIMULATOR.

    Description of Event or Problem · 0

    APPROXIMATELY IN (B)(6) 2018 THE RECIPIENT NOTICED THE RECEIVER STIMULATOR WAS STARTING TO EXTRUDE POST AURICULARLY AND CONTINUED TO MIGRATE OUT THROUGH A POST AURICULAR FISTULA. AS A RESULT OF THE EXTRUSION, THE EXTERNAL PROCESSOR COULD NOT BE WORN. THERE IS NO ALLEGATION THAT THE EXTERNAL PROCESSOR CONTRIBUTED TO THE PROBLEM. THE RECIPIENT WAS EXPLANTED ON (B)(6) 2018. NO NEW DEVICE WAS PLACED. PER DEVICE EXPLANTATION REPORT, THE ELECTRODE ARRAY TIP WAS DAMAGED DUE TO RE-INSERTION ATTEMPT. THE LEADING EDGE OF THE DEVICE WAS EXPOSED BEHIND THE AURICLE. THE DEVICE WAS FOUND COMPLETELY FIXED. ALSO PER REPORT, THE RECIPIENT HAD CHRONIC PAIN IN THE REGION OF THE STIMULATOR AND A SLOW INCREASE IN SIZE OF A PSEUDO CAPSULE. THERE WAS A CONSIDERABLE FIBROTIC CAPSULE AND EDEMATOUS TISSUE IN CONTACT WITH THE STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718611 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY 09008737094041

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention