BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE

    MDR report key: 24330653 · Received February 13, 2026

    Report

    Report Number
    6000034-2026-00570
    Event Type
    Injury
    Date Received
    February 13, 2026
    Report Date
    April 28, 2026
    Manufacturer
    COCHLEAR LIMITED
    Product Code
    MCM
    UDI-DI
    09321502053099
    PMA / PMN Number
    P970051/S225
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION G4: THE CORRECT PMA/510(K) IS P970051/S225, NOT P970051 AS PREVIOUSLY REPORTED. PER THE CLINIC, THE PATIENT EXPERIENCED PURULENT DISCHARGE AROUND THE IMPLANT SITE. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED EDEMA AND DEVELOPED AN INFECTION AT THE INCISION SITE. SUBSEQUENTLY, THE PATIENT UNDERWENT SKIN REVISION OF DEBRIDEMENT (SPECIFIC DATE NOT REPORTED) AND TREATED WITH ORAL ANTIBIOTICS FOR A DURATION OF 20 DAYS (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36037 COCHLEAR¿ NUCLEUS® NEXA® COCHLEAR IMPLANT WITH SLIM MODIOLAR ELECTRODE COCHLEAR¿ NUCLEUS® NEXA® SYSTEM MCM COCHLEAR LIMITED CI1032 NA 09321502053099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention