BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1781209 · Received August 3, 2010

    Report

    Report Number
    6000034-2010-00511
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    July 28, 2010
    Report Date
    September 17, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.(B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED A CHOLESTEATOMA RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6), 2010. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM (AIR IN LINE), WHICH WAS FOUND BY THE PERITONEAL DIALYSIS (PD) NURSE WHILE DOWNLOADING THE HOME PATIENT'S (HP) PROCARD. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MEANING OF THE ALARM. THE TSR ADVISED THE PD NURSE TO INSTRUCT THE HP TO CALL WHEN THE ALARM OCCURS. THE SAMPLE WAS DISCARDED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE RN. PRODUCT SURVEILLANCE CONTACTED THE PD NURSE REGARDING THE REPORTED PROBLEM. THE PD NURSE STATED SHE SPOKE TO BOTH THE PATIENT AND HIS SON AND INSTRUCTED THE PATIENT TO CALL THE BAXTER 800 NUMBER AS WELL AS THE DIALYSIS CENTER WHENEVER HE RECEIVES A SYSTEM ERROR 2240 ALARM. THE SAMPLE WAS DISCARDED AND THERE WAS NO INJURY OR MEDICAL INTERVENTION. THE HOME PATIENT IS CONTINUING THERAPY ON THE CYCLER WITH NO FURTHER ISSUES.

    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 6 YR Required Intervention