BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1790664 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01505
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    October 12, 2007
    Report Date
    October 16, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. LEAD IS CUT ABOUT 3 CM AND 10 CM FROM THE TERMINAL END. LEAD PASSES CONTINUITY TESTING, HOWEVER, FLEX TESTING INDICATE THAT ONE CHANNEL IS INTERMITTENT. THIS CHANNEL WAS NOT PROGRAMMED FOR USE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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 RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG AND A SINGLE PERCUTANEOUS LEAD (DATE NOT AVAILABLE). IT WAS REPORTED THAT THE PT FELL FROM A LADDER ON (B)(6) 2007. REPORTEDLY, THE PT PROGRAMMER STILL FUNCTIONED AND THE PT WAS RECEIVING STIMULATION BUT THE STIMULATION TURNED OFF WHEN THE PROGRAMMER WAND WAS REMOVED FROM OVER THE IPG. IN ADDITION, THE STIMULATION WAS IN THE WRONG AREA. THE PT FELT STIMULATION IN HIS CHEST. A REPLACEMENT PROGRAMMER DID NOT RESOLVE THE ISSUE. THE IPG AND THE LEAD WERE REMOVED ON (B)(6) 2007 AND RETURNED TO ANS FOR ANALYSIS. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ADVANCED NEUROMODULATION SYSTEMS 3186 34536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention