BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW SINGLE RECEIVER, 8-CHANNEL

    MDR report key: 1800007 · Received August 12, 2010

    Report

    Report Number
    1627487-2010-01437
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE PATIENT IS NO LONGER FEELING STIMULATION AND REPLACEMENT TRANSMITTER AND ANTENNA DID NOT ADDRESS THE ISSUE. THE PATIENT WILL UNDERGO AN EXPLANT AND RECEIVE A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW SINGLE RECEIVER, 8-CHANNEL IMPLANTED SPINAL CORD STIMULATOR GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3408 33802

    Patients

    Seq Age Sex Outcome Treatment
    1