BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 8 PERCUTANEOUS TRIAL LEAD

    MDR report key: 1880318 · Received October 20, 2010

    Report

    Report Number
    1627487-2010-02844
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND 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. 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

    ON (B)(6) 2010, IT WAS REPORTED THAT DURING THE TRIAL LEAD IMPLANT PROCEDURE, THERE WAS A DURAL TEAR AND CSF LEAKAGE. THE PHYSICIAN PERFORMED A BLOOD PATCH TO STOP THE CSF LEAKAGE, AND THE IMPLANTATION PROCEDURE WAS ABORTED. THE LEAD WAS NEVER PLACED AND WAS DISCARDED BY THE PHYSICIAN. THE PATIENT IS SCHEDULED TO BE IMPLANTED WITH A NEW TRIAL LEAD ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS TRIAL LEAD IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 3161531

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention