BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1829723 · Received September 9, 2010

    Report

    Report Number
    6000034-2010-00599
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 8, 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

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE MAGNET BECAME DISLODGED AFTER THE PATIENT SUSTAINED A BLOW TO THE HEAD. THE MAGNET WAS REPLACED ON (B)(6), 2010, NOT (B)(6), 2010 AS PREVIOUSLY REPORTED. THE IMPLANTED DEVICE REMAINS. CORRECTION: THE CORRECT MFR REPORT # IS 6000034-2010-599, NOT 6000034-2010-720 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(6), 2010. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT SUSTAINED A BLOW TO THE HEAD, RESULTING IN A DISLODGED MAGNET. THE PATIENT UNDERWENT SURGERY TO INSERT A NEW STERILE MAGNET ON (B)(6), 2010.

    Description of Event or Problem · 1

    THE STUDY COORDINATOR CONFIRMED THE PATIENT HAD RESTENOSIS OF THE CYHER STENTS IN THE PROXIMAL AND MID RIGHT CORONARY ARTERIES. SHE STATED THE CYPHER STENT IMPLANTED IN THE PROXIMAL RCA WAS RESTENOSED AND THAT TREATMENT INCLUDED BALLOON ANGIOPLASTY ONLY. SHE STATED SHE COULDN'T CONFIRM WHICH CYPHER STENT IN THE MID RCA HAD RESTENOSIS. SHE STATED THAT A XIENCE STENT WAS IMPLANTED IN THE MID RCA AS TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention