BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL 4 LEAD EXTENSION

    MDR report key: 1904116 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02373
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    January 22, 2010
    Report Date
    January 26, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 4 OF 5. 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. 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 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

    DEVICE 4 OF 5. REFERENCE MANUFACTURER REPORT: 1627487-2010-02370 AND 1627487-2010-02371, 1627487-2010-02372, 1627487-2010-02374. THE PT REC'D HER SCS SYSTEM INCLUDING AN IPG, PERCUTANEOUS LEADS AND LEAD EXTENSIONS ON (B)(6) 2010. HER SYSTEM WAS IMPLANTED FOR PERIPHERAL NERVE STIMULATION (PNS) WHICH IS AN OFF-LABEL INDICATION. IT WAS REPORTED THAT THE PT EXPERIENCED A BURNING SENSATION IN THE IPG POCKET SITE WHEN THE STIMULATION FOR A PARTICULAR LEAD SHE HAS IS USED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD, BUT THE PROCEDURE WAS NOT SUCCESSFUL. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM. THE EXPLANTED DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL 4 LEAD EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3341 172615

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention