BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1622494 · Received March 4, 2010

    Report

    Report Number
    6000034-2010-00129
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    January 29, 2010
    Report Date
    May 25, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER CONVERTED TO TROPONIN T HIGH SENSITIVE (HS) ASSAY AND TESTED SAMPLES FOR ONE WEEK ON BOTH THIS ANALYZER AND A DIFFERENT E601 MODULE AND OBTAINED DIFFERING RESULTS. RESULTS FOR 10 PATIENT SAMPLES WERE PROVIDED, SIX WERE DISCREPANT. THE E601 ANALYZERS HAVE DIFFERENT UNITS OF MEASURE FOR THE TROPONIN T HS ASSAY. PATIENT 1, INITIAL TROPONIN T HS RESULT 137.9 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 0.10 UG/L (DIFFERENT E601) AND 138.4 NG/L (ORIGINAL ANALYZER, ACCOMPANIED BY H DATA FLAG). PATIENT 2, INITIAL TROPONIN T HS RESULT 17.75 NG/L, REPEATED TWICE GAVE 3.70 UG/L (DIFFERENT E601) AND 41.04 NG/L (ORIGINAL ANALYZER). PATIENT 3, INITIAL TROPONIN T HS RESULT 1860 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 1.57 UG/L (DIFFERENT E601) AND 6.90 NG/L (ORIGINAL ANALYZER). PATIENT 4, INITIAL TROPONIN T HS RESULT 84.46 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 0.06 UG/L (DIFFERENT E601) AND 82.99 NG/L (ORIGINAL ANALYZER, ACCOMPANIED BY H DATA FLAG). PATIENT 5, INITIAL TROPONIN T HS RESULT 56.03 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED TWICE GAVE 0.04 UG/L (DIFFERENT E601) AND 55.72 NG/L (ORIGINAL ANALYZER, ACCOMPANIED BY H DATA FLAG). PATIENT 6, INITIAL TROPONIN T HS RESULT 291.4 NG/L (ACCOMPANIED BY H DATA FLAG), REPEATED ONCE GAVE 0.24 UG/L (DIFFERENT E601). IT IS UNKNOWN WHICH TROPONIN T HS RESULTS WERE REPORTED. NO ADVERSE EVENTS WERE REPORTED. TROPONIN T HS REAGENT LOT IS 156593. INVESTIGATION IS ON-GOING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED A DECREASE IN PERFORMANCE. THE RESULTS OF AN INTEGRITY TEST (B) (6) 2009 INDICATE NORMAL RECEIVER STIMULATOR FUNCTION WITH MULTIPLE ELECTRODE ANOMALIES. THE RESULTS OF A CT SCAN INDICATED NORMAL PLACEMENT OF THE DEVICE. THE PATIENT WAS EXPLANTED (B) (6) 2010 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    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 64 YR Required Intervention