BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENEW RECEIVER

    MDR report key: 1793648 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01884
    Event Type
    Death
    Date Received
    August 6, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 14, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: RECEIVER WAS RETURNED WITH TWO INCOMPLETE LEADS AND TWO STRAIN RELIEFS. THE RETURNED LEADS ARE CUT AT THE STIMULATION END. RECEIVER HAS THE OLD STYLE LEAD FRAME. RECEIVER HAS BROWNISH DISCOLORATION IN THE HEADER, WHICH IS CONSISTENT WITH CORROSION FROM THE OLD STYLE LEAD FRAME. THE RECEIVER FAILED AUTO TESTING. CONCLUSION: THE COMPLAINT ABOUT "DEATH" COULD NOT BE CONFIRMED; THE PRODUCT FAILS FUNCTIONAL TESTING BECAUSE OF OLD STYLE LEAD FRAME CORROSION. NO FURTHER ANALYSIS CAN BE DONE BECAUSE OF LACK OF PERTINENT INFO ON IMPLANT-EXPLANT DATES AND PROGRAM SETTINGS. ANS HAS LIMITED INFO RELATED TO THE PT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT¿S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN SCS SYSTEM. A PT EXPIRED IN THE VA HOSPITAL AND THE HOSPITAL STAFF WANTED TO RETURN THE PRODUCT. THE HOSPITAL STAFF STATED THAT THE DEATH WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW RECEIVER GZB/LGW GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3416

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O