BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1231656 · Received November 14, 2008

    Report

    Report Number
    6000034-2008-00658
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 20, 2008
    Report Date
    April 13, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED, 11/14/08.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ON THE HOMECHOICE (HC) DURING DWELL 3 OF 6. HOME PATIENT (HP) STATED SHE NOTICED ONE OF THE BAGS FELL AND DISCONNECTED. TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ALARM AND HAD THE HP CLOSE ALL CLAMPS THEN CYCLE POWER TO CLEAR BOTH THE SE 2240 AND 2367. TSR ADVISED HP TO DISCARD SUPPLIES AND START OVER WITH NEW ONES. PRODUCT SURVEILLANCE FOLLOWED UP (B)(6) 2010 WITH THE HP WHO REPORTED THE DISCONNECTION WAS BETWEEN THE LINE AND THE BAG. HP DID NOT NOTICED ANY DEFECT OR PROBLEMS WITH THE BAG OR CASSETTE PRIOR TO USE. THE HP STATED THE DISCONNECT WAS DUE TO HUMAN ERROR. THE BAG WAS ON A LITTLE STAND AND AS THE FLUID DRAINED OUT, THE BAG SHIFTED AND FELL. THE HP CONFIRMED AS PREVIOUSLY REPORTED THAT THE SUPPLIES WERE DISCARDED AND THE LOT NUMBER WAS UNKNOWN. THE HP CONFIRMED SHE CONTINUED THERAPY WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    A NEW CASE OF MENINGITIS WAS REPORTED TO COCHLEAR AMERICAS IN 2008. PER THE AUDIOLOGIST, APPROX 40 DAYS AFTER THE COCHLEAR IMPLANT SYSTEM WAS ACTIVATED (DATE NOT REPORTED), THE PT WAS ADMITTED TO THE HOSP WITH BACTERIAL MENINGITIS. HE WAS RELEASED FROM THE HOSP AFTER A WEEK. NO FURTHER INFO WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Life Threatening| R