BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1820961 · Received August 31, 2010

    Report

    Report Number
    6000034-2010-00578
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 24, 2010
    Report Date
    January 20, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PER PATIENT'S AUDIOLOGIST, THE DEVICE WAS EXPLANTED AND THE PATIENT WITH A NEW DEVICE ON AN UNKNOWN DATE. THIS REPORT IS FILED (B)(4), 2011.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT RESULTING IN THE DECISION TO DISCONTINUE USE OF THE DEVICE. THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS INITIALLY REPORTED THAT AN EDWARDS VALVE WAS EXPLANTED ON (B)(6) 2010. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT WAS LEARNED THAT THE DEVICE EXPLANTED ON (B)(6) 2010 WAS A MEDTRONIC PORCINE VALVE. HOWEVER, UPON REVIEW OF THE OPERATIVE REPORT IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY HAD AN EDWARDS VALVE (IMPLANTED IN 2001). THE PATIENT HAD SURGERY ON HER ANKLE IN 2004 AND DEVELOPED ENDOCARDITIS. SHE THEN UNDERWENT REDO AORTIC VALVE REPLACEMENT, AT WHICH THE EDWARDS VALVE WAS EXPLANTED AND THE MEDTRONIC VALVE WAS IMPLANTED. NO OTHER DETAILS REGARDING THE EXPLANT OF THE EDWARDS VALVE IN 2004 ARE AVAILABLE.

    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 24 YR Required Intervention