BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3161757 · Received June 5, 2013

    Report

    Report Number
    9710014-2013-00220
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    February 2, 2012
    Report Date
    May 31, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PT STARTED HAVING TO PUT PRESSURE ON THE COIL TO HAVE ACCESS TO SOUND. SINCE THEN HE HAS NOT BEEN USING HIS AUDIO PROCESSOR. THE PT'S SKIN FLAP APPEARS TO BE SWOLLEN/THICK. REVISION SURGERY WAS HELD ON (B)(6) 2013, FOR THINNING THE PT'S SKIN FLAP. THE SURGEON DECIDED TO RE-IMPLANT THE PT DURING THE SAID SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248927 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention