BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1904090 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02089
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    April 9, 2008
    Report Date
    April 30, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2. EVAL: 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 INFORMATION 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 2 OF 2. REFERENCE MFR REPORT # 1627487-2010-02088. THE PT RECEIVED HER SCS SYSTEM INCLUDING TWO PERCUTANEOUS LEADS AND AN IPG ON (B)(6) 2005. THIS PT USES A WHEELCHAIR AND SITS BENT FORWARD WHILE FAVORING ONE SIDE. IT WAS REPORTED THAT THE LEADS MIGRATED AND THE PT LOST STIMULATION TO THE DESIRED AREAS. THE PT WAS REPROGRAMMED REPEATEDLY BUT THE ALLEGED ISSUE CONTINUED. THE LEADS WERE SURGICALLY REPOSITIONED ON (B)(6) 2008. NO PRODUCT WAS EXPLANTED. NO FURTHER INFORMATION 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 39997

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention