BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1904077 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02221
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 23, 2009
    Report Date
    September 24, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 MANUFACTURER REPORT: 1627487-2010-02222. THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT ONE OF THE PATIENT'S LEADS WAS EXHIBITING UNACCEPTABLE IMPEDANCES. AN X-RAY FOUND THAT THE LEAD HAD PULLED OUT OF THE IPG HEADER. THE LEAD WAS SURGICALLY RECONNECTED TO THE IPG. THE LEAD AND DEVICE WERE NOT EXPLANTED. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED. NO PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 2807559

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention