BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1820884 · Received August 31, 2010

    Report

    Report Number
    6000034-2010-00569
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 13, 2010
    Report Date
    March 18, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED (B)(6), 2010. DURING THE SAME SURGERY, THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AN INTEGRITY TEST WAS CARRIED OUT ON (B)(6), 2010. IT WAS DETERMINED TO BE A FAILED INTEGRITY TEST. RESULTS REVEALED MALFUNCTION OF THE RECEIVER STIMULATOR, AS WELL AS MULTIPLE ELECTRODE ANAMOLIES.REVISION SURGERY IS SCHEDULED BUT HAS NOT TAKEN PLACE AS OF DATE ON THIS REPORT.(B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY HIGH PLATELET RESULT GENERATED BY ACT 5DIFF CP INSTRUMENT ON FIRST ASPIRATION OF A PATIENT SPECIMEN WITH A FLAG. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING PRODUCED LOWER PLATELET RESULT, WHICH THE CUSTOMER CONSIDERS CORRECT. NO MANUAL SCANS WERE PERFORMED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED AT THE TIME OF THE INDEX PROCEDURE WITH CCS CLASS III STABLE ANGINA. ON THE DATE OF THE INDEX PROCEDURE, THE PATIENT HAD A TEMPORARY PACEMAKER PLACED DUE TO BRADYCARDIA. THE TEMPORARY PACEMAKER WAS REMOVED AFTER FIVE DAYS. THE PATIENT WAS DISCHARGED 16 DAYS POST INDEX PROCEDURE WITH CCS CLASS II STABLE ANGINA. CORRECTED INFORMATION STATED THAT THE INDEX PROCEDURE WAS 80MM IN LENGTH, NOT 86MM. THE INDEX LESION WAS 90% STENOSED, NOT 82% AS INITIALLY REPORTED AND RESIDUAL STENOSIS WAS 0%, NOT 20%.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT HAS EXPERIENCED NAUSEA, VERTIGO, AND POPPING SOUNDS WHILE USING THE DEVICE. THE PATIENT HAS DISCONTINUED USE OF THE DEVICE. EXPLANT AND REIMPLANTATION IS PLANNED, BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

    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