BEUDAMED
    FDA Adverse Event Death Summary report: N

    MED-EL-ADVANCED BIONIC CORP

    MDR report key: 351478 · Received September 12, 2001

    Report

    Report Number
    MW1022843
    Event Type
    Death
    Date Received
    September 12, 2001
    Date of Event
    July 29, 2001
    Manufacturer
    ADVANCED BIONIC CORP.
    Product Code
    MCM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/20/01: MED-EL HAS REVIEWED THE INFO AVAILABLE UNDER REPORT AS DISPLAYED IN THE MAUDE DATABASE MDR TEXT KEY 1219883. MFR HAS CONCLUDED THAT THE INFO CONTAINED THEREIN DOES NOT REPRESENT A DEVICE THAT IS MFG BY ITS FIRM. THIS CONCLUSION IS BASED ON THE INFO CONTAINED IN THE DEVICE LOT NUMBER, WHICH STATES HIFOCUS-ELECTRODE SYSTEM. THIS SYSTEM IS AN ADVANCE BIONICS CORP BRAND NAME. MED-EL FURTHER REQUESTS THE REMOVAL OF THE NAME MED-EL FROM THE FIELD BRAND NAME. MED-EL IS CONCERNED THAT THE INFO CONTAINED WITHIN THE REPORT IS MISLEADING AND HARMFUL TO THE REPUTATION OF MED-EL. THIS APPEARS TO BE ESPECIALLY PROBLEMATIC ON REPORTS THAT ARE NOT PROVIDED BY EITHER HEALTHCARE PRACTITIONERS OR MFRS.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 10/25/01: MFR WOULD LIKE TO INFORM THAT THE BRAND NAME "MED-EL-ADVANCED BIONICS CORPORATION" INDICATED IN "SUSPECT MEDICAL DEVICE" SECTION OF THE MED WATCH FORM IS NOT AN ADVANCED BIONICS PRODUCT. FURTHER, MFR'S RECORDS INDICATE THAT THEY HAVE NOT RECEIVED ANY COMPLAINTS OF THIS TYPE FROM IT'S DEVICE USERS OR THE CLINICS. THEREFORE, ADVANCED BIONICS DETERMINED THAT THE EVENT DOES NOT REQUIRE A MEDICAL DEVICE REPORT.

    Description of Event or Problem · 1

    DEATH. PERMANENT DISABILITY. 2-3 MILLION IN PROPERTY DAMAGE. USED ON SOMEONE WHO CAN HEAR. TO AUTOMIZE THE INDIVIDUAL POLICE INTERVENTION WAS NEEDED. THEY ARE BEING USED BY THE PRESS AND ATTYS TO MAKE MONEY, OR FRAUD. THEY ARE NOW USED FOR INTERROGATIONS BY NON-EMPLOYEES AND ON ORGANIZED CRIME GROUPS. THEY ARE ALSO USED FOR INSIDER TRADING OF SECURITIES. WEAPONS RESEARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41325 MED-EL-ADVANCED BIONIC CORP COCHLEAR IMPLANTS MCM ADVANCED BIONIC CORP. UNDER INVESTIGATION HIFOCUS ELECTRODE SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Congenital Anomaly| D| L| O| R| S 7. DIALYSIS 1386-1 AND 92541.| 4. URINE TESTS. 5. BLOOD TEST. 6. X-RAY.| 1. CARDIOLOGY DEVICES. 2. MRI. 3. BRAIN SCANS.