BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7262618 · Received February 11, 2018

    Report

    Report Number
    9710014-2018-00105
    Event Type
    Injury
    Date Received
    February 11, 2018
    Date of Event
    January 24, 2018
    Report Date
    March 15, 2018
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MED-EL ELEKTROMEDIZINISCHE GERAETE (B)(4) AND VIBRANT MED-EL SUBMIT MDR REPORTS ON BEHALF OF MED-EL CORPORATION (EXEMPTION NUMBER E2015033). REPORTEDLY, THE RECIPIENT WAS WEARING A HELMET FOR JOB REASONS FOR SEVERAL WEEKS. THE PRESENCE OF THE HELMET LYING ON THE SKIN OVER THE IMPLANT MOST LIKELY CAUSED THE SURGICAL INCISION TO OPEN, CONSEQUENTLY LEADING TO DEVICE EXPOSURE. THEREAFTER, THE DEVICE WAS EXPLANTED. REPORTEDLY, THE USER WAS DOING VERY WELL WITH THE DEVICE. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION AS IT WAS LOST AFTER EXPLANTATION AT THE CLINIC. THIS IS A FINAL REPORT.

    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.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO AN ACCIDENT/TRAUMA. PER NEW INFORMATION RECEIVED, THE PATIENT HAD BEEN WEARING A HARD HAT FOR HIS JOB FOR SEVERAL WEEKS. REPORTEDLY, THE HARD HAT WAS RUBBING ON AN AREA OF THE IMPLANT AND CAUSED THE SURGICAL INCISION TO OPEN. THE PATIENT THEN PRESENTED AT THE CLINIC AS PART OF THE IMPLANT EXTRUDED THROUGH THE SKIN. THEREFORE THE DEVICE WAS EXPLANTED. SURGERY TO IMPLANT A NEW DEVICE IS SCHEDULED. THE DEVICE HAS REPORTEDLY BEEN LOST AND WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO AN ACCIDENT/TRAUMA. PER NEW INFORMATION RECEIVED, THE PATIENT HAD BEEN WEARING A HARD HAT FOR HIS JOB FOR SEVERAL WEEKS. REPORTEDLY, THE HARD HAT WAS RUBBING ON AN AREA OF THE IMPLANT AND CAUSED THE SURGICAL INCISION TO OPEN. THE PATIENT THEN PRESENTED AT THE CLINIC AS PART OF THE IMPLANT EXTRUDED THROUGH THE SKIN. THEREFORE THE DEVICE WAS EXPLANTED. THERE IS NO ALLEGATION AGAINST THE DEVICE. SURGERY TO IMPLANT A NEW DEVICE IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105876 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention