BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1790811 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01345
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    January 29, 2009
    Report Date
    February 4, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 3. EVALUATION, METHOD: 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. FAILED CONTINUITY TEST. LEAD HAS BROKEN WIRES IN THE LEAD SEGMENT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT # 1627487-2010-01346 AND MFR REPORT# 1627487-2010-01347. THE PT RECEIVED HIS SCS SYSTEM INCLUDING PERCUTANEOUS LEADS ON (B)(6) 2008. IT WAS REPORTED THAT THE PT LOST STIMULATION. INTRAOPERATIVE TESTING SHOWED THAT TWO LEADS WERE NON-FUNCTIONAL. THE LEADS WERE REPLACED ON (B)(6) 2009. IT WAS NOT NOTED FROM WHICH LOTS THE EXPLANTED LEADS CAME FROM, SO ALL THREE LOTS ISSUED TO THE PT ARE INCLUDED IN THIS REPORT. THE EXPLANTED LEADS WERE RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 97348

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention