BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2012290 · Received March 9, 2011

    Report

    Report Number
    6000034-2011-00151
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    January 19, 2011
    Report Date
    May 13, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: FURTHER INVESTIGATION REVEALED THE DEVICE WAS NOT EXPLANTED. THE MDR WAS FILED IN ERROR. THE IMPLANTED DEVICE REMAINS. THERE WAS NO ALLEGED DEFICIENCY OR SERIOUS INJURY ASSOCIATED WITH THIS DEVICE. THIS REPORT IS FILED (B)(4), 2011. IMPLANTED DEVICE REMAINS

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO SUSPECTED BUT UNSPECIFIED DEVICE PROBLEM. THE DEVICE WAS EXPLANTED ON (B)(6), 2011 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY. THE MANUFACTURER BECAME AWARE UPON RECEIPT OF THE EXPLANTED DEVICE ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention