BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1760330 · Received July 16, 2010

    Report

    Report Number
    6000034-2010-00461
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 14, 2010
    Report Date
    August 24, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECT DATE OF EVENT IS (B)(6) 2010, NOT (B)(6) 2010 AS PREVIOUSLY REPORTED. (B)(4). DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED.EXPLANT AND REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2010-03793. SAME PATIENT AS: 2134265-2010-03603, 2134265-2010-03602, 2134265-2010-03604. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED DISSECTION. THE PATIENT WAS PRESENTED IN CARDIAC ARREST WITH ABNORMAL EKG CHANGES AND AN ACUTE INFERIOR MYOCARDIAL INFARCTION. UNDER LOCAL ANESTHESIA, ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. A CARDIAC CATHETERIZATION FOUND A COMPLETE OCCLUSION OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PATIENT HAD INITIALLY RECEIVED AN ANGIOMAX BOLUS FOLLOWED BY AN ANGIOMAX DRIP. THE PATIENT ALSO RECEIVED INTRACORONARY NITROGLYCERIN. A NON-BSC GUIDEWIRE WAS ADVANCED, WHICH WAS UNSUCCESSFUL. A 2.5X12MM APEX BALLOON WAS UNABLE TO CROSS THE TOTALLY OCCLUDED RCA. A 2.5X15MM APEX BALLOON WAS ADVANCED TO THE PROXIMAL RCA WHICH WAS INFLATED TO 10 ATMS AND 12 ATMS FOR 30 SECONDS EACH. THE PHYSICIAN THEN INSERTED A 2.0X12MM APEX BALLOON TO THE PROXIMAL RCA WHICH WAS INFLATED TWICE TO 18 ATMS AND 10 ATMS FOR 45 AND 30 SECONDS TO OPEN UP THE STENOTIC AREA. A REPEAT ANGIOGRAM REVEALED MULTIPLE LONG DISSECTIONS. THE PHYSICIAN IMPLANTED A 2.5X24MM TAXUS LIBERTE STENT IN THE PROXIMAL RCA WITH A MAXIMUM PRESSURE OF 12 ATMS, FOLLOWED BY THE PLACEMENT OF A 2.5X24MM AND 2.5X16MM TAXUS LIBERTE STENTS IN THE RCA. REPEAT ANGIOGRAPHY REVEALED SUCCESSFUL BALLOON ANGIOPLASTY AND MULTIPLE STENTS PLACEMENT WITH NO RESULTING STENOSIS. PATIENT STATUS LISTED AS "FINE."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention