BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1790912 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01557
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    March 6, 2009
    Report Date
    April 30, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. FAILED CONTINUITY TEST. 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 RECEIVED HIS SCS SYSTEM ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE IPG WOULD NO LONGER COMMUNICATE WITH THE CHARGER. THIS WAS REPORTED ON MFR REPORT # 1627487-2009-00068. IT WAS LATER MADE KNOWN THAT DURING THE IPG REPLACEMENT, THE PHYSICIAN FELT THAT THE LEADS COULD HAVE BEEN PART OF THE REPORTED PROBLEM AND DECIDED TO REPLACE THEM AS WELL. 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 2751892

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention