BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1946070 · Received January 4, 2011

    Report

    Report Number
    6000034-2010-00827
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 10, 2010
    Report Date
    May 13, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: DEVICE WAS EXPLANTED ON (B)(6), 2010, NOT (B)(6), 2010 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4), 2011.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED DID NOT WEAR A MASK (DATE OF ONSET NOT REPORTED). ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IT WAS UNKNOWN WHETHER A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. TREATMENT FOR THE EVENTS WERE NOT REPORTED. DIANEAL PD4 AMBUFLEX THERAPY WAS ONGOING. THE OUTCOME FOR THE EVENT OF DID NOT WEAR A MASK WAS NOT REPORTED. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING FROM THE EVENT OF PERITONITIS AT THE TIME OF REPORTING. A CAUSALITY STATEMENT WAS NOT REPORTED FOR THE EVENT OF DID NOT WEAR A MASK. PER THE NURSE, THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND PAIN WITH DEVICE USE RESULTING IN THE DECISION TO EXPLANT THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6), 2010 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention