BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1760325 · Received July 16, 2010

    Report

    Report Number
    6000034-2010-00459
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    June 23, 2010
    Report Date
    December 8, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF AWARENESS IS (B)(6), 2010, NOT (B)(6), 2010 AS PREVIOUSLY REPORTED.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ON (B)(6) 2010 ALLEGING INACCURATE HIGH READINGS ON THE PATIENT'S ONE TOUCH ULTRA 2 METER. A MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNSUCCESSFUL IN GETTING A HOLD OF THE PATIENT AND SENT A LETTER TO OBTAIN FURTHER CLINICAL INFORMATION: THE PATIENT NOTICED THE HIGH READINGS ON (B)(6) 2010. THE PATIENT OBTAINED A 146 MG/DL ON THE LFS METER AND APPROXIMATELY 2 DAYS LATER, THE PATIENT DEVELOPED CHEST PAINS AND WENT TO THE FIRE DEPARTMENT AND WAS TESTED ON THEIR METER AND OBTAINED A 90 MG/DL AND WAS TREATED WITH FOOD/DRINK AND WAS ADMITTED IN THE HOSPITAL. THE PRODUCTS WERE REPLACED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW HOW LONG THE PATIENT WAS ADMITTED IN THE HOSPITAL, THE DIAGNOSIS, READINGS PRIOR TO THE EVENT AND TREATMENT IN THE HOSPITAL. IT WOULD HAVE BEEN ALSO HELPFUL TO KNOW WHETHER THE 90 MG/DL RESULT WAS AFTER TREATMENT OR BEFORE TREATMENT ON THE FIRE DEPARTMENT'S METER. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT WAS TREATED WITH FOOD/DRINK BY THE FIRE DEPARTMENT AND WAS ADMITTED IN THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL PROCEDURE, THE 4193 LV LEAD COULD CAPTURE VIA THE ANALYZER BUT NOT AFTER HOOKING UP TO THE DEVICE. IN A LATER PROCEDURE, THE 4193 LEAD WAS EXPLANTED BECAUSE OF OBSERVED HIGH THRESHOLD RESULTING IN NO PACING CAPTURE. AN IMPLANT ATTEMPT WAS MADE TO REPLACE WITH A 4196 LEAD BUT THAT WAS UNSUCCESSFUL DUE TO CHALLENGES WITH THE PATIENT ANATOMY. AN EPICARDIAL LEAD WILL BE ATTEMPTED IN THE NEAR FUTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS EXPERIENCING POOR PERFORMANCE WITH THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE 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. CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention