BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 1823423 · Received August 25, 2010

    Report

    Report Number
    1627487-2010-01961
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    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 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. THE PT CANNOT TURN STIMULATION UP PAST PERCEPTION. THE REP IDENTIFIED THAT THERE WERE SOME INVALID READINGS ON THE CONTACTS THROUGHOUT THE LEAD. PT CANNOT TURN STIMULATION UP PAST PERCEPTION. THE PT ONLY HAD ONE PROGRAM TO TRY AND THE IPG IS FULLY CHARGED. PT HAS MULTIPLE SYSTEMS, SO IT CANNOT BE DETERMINED WHAT LEAD IS THE PROBLEM. THE PT IS GETTING INEFFECTIVE STIMULATION. REVISION IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other