BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1790890 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01599
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 17, 2009
    Report Date
    July 21, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. ALL WIRES BROKEN AND LEAD FAILED CONTINUITY TESTING. 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 2. REFERENCE MFR REPORT # 1627487-2010-01600. THE PT RECEIVED HER SCS SYSTEM CONSISTING OF TWO LEADS AND AN IPG ON (B)(6) 2008. IT WAS REPORTED THAT ALL LEAD CONTACTS BECAME INVALID AND THE IPG BECAME UNCOMFORTABLE. IT WAS ALSO REPORTED THAT THE PT HAD LOST A SIGNIFICANT AMOUNT OF WEIGHT. THE SYSTEM WAS REPLACED ON (B)(6) 2009, WITH THE PT RECEIVING A SMALLER MODEL IPG. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED LEADS AND IPG 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 114345

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention