BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1132429 · Received August 22, 2008

    Report

    Report Number
    6000034-2008-00475
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 19, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT, FILED AUGUST 22, 2008. - RESULTS/FINDINGS OF ANALYSIS: THERE WAS A TEAR ON THE SIDE OF THE STIMULATOR CLOSE TO THE HELIX EXIT. THE RESULTS OF TESTS PERFORMED WITH THE DEVICE IN SALINE SOLUTION SHOWED THAT THE TEAR IN THE SILICONE CARRIER CAUSED A BREACH IN THE ELECTRICAL INSULATION OF THE ELECTRODE WIRE ASSEMBLY. THE DEVICE PASSED ALL TESTS CONDUCTED WHEN IT WAS DRY. DETAILS OF ANALYSIS: THERE WAS A TEAR ON THE SIDE OF THE STIMULATOR CLOSE TO THE HELIX EXIT. BENDS AND KINKS CONSISTENT WITH EXPLANTATION WERE OBSERVED ALONG THE ELECTRODE LEAD AND ARRAY. ELECTRODE RING E1 AND STIFFENING RINGS S2 TO S5 AND S8 TO S10 WERE CRUSHED. THE DEVICE WAS OPENED TO THE OUTER FEEDTHROUGH AREA. THERE WAS EVIDENCE OF THE BODY FLUID INGRESS INTO THE OUTER FEEDTHROUGH AREA. THE DEVICE WAS SOAKED IN 9G/L SALINE SOLUTION FOR 24 HRS. CONSISTENT WITH THE DAMAGES DESCRIBED ABOVE, ELECTRICAL LEAKAGE WAS OBSERVED AT THE LOCATION OF THE TEAR. THE DEVICE PASSED ALL THE OTHER TESTS INCLUDING REMOTE, REFLECTED RECEIVER COIL IMPEDANCE, IMPLANT LOAD AND TWO POINT PROBE TESTS CONDUCTED WHEN DRY.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT DECIDED TO HAVE THE DEVICE ELECTIVELY EXPLANTED. THE PT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. DURING DEVICE ANALYSIS, A FAULT WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24M

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention