BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1813474 · Received August 24, 2010

    Report

    Report Number
    6000034-2010-00560
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 6, 2010
    Report Date
    March 7, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CORRECT DATE OF SURGERY IS (B)(6), 2010, NOT (B)(4), 2010 AS PREVIOUSLY REPORTED.THERE ARE NO PLANS FOR REIMPLANTATION AS OF THE DATE OF THIS REPORT.(B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A MIGRATION OF THE ELECTRODE ARRAY RESULTING IN A DECISION TO EXPLANT THE DEVICE. THE PATIENT HAS NEVER BEEN STIMULABLE DESPITE NUMEROUS PROGRAMMING ATTEMPTS.

    Description of Event or Problem · 1

    THE ACCOUNT ALLEGED THE HEAD OF BED WOULD RISE AND THEN LOWER ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (ST) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention