BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1852469 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02509
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    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

    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 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

    THE DOCTOR OPENED THE LEAD KIT AND INSERTED THE EPIDURAL NEEDLE AT L1. THERE WAS A CSF LEAK AS A RESULT OF THE DURAL PUNCTURE. THE DOCTOR ABORTED THE SCS IMPLANT CASE (STANDARD OPERATING PRACTICE WHENEVER A DURAL PUNCTURE OCCURS). THE PT'S DOCTOR WILL RESCHEDULE THE CASE FOR A LATER DATE. THE EPIDURAL NEEDLE WAS PART OF THE LEADS KIT, THE LEAD WAS NEVER PLACED IN THE PT AND LEAD KIT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD, IMPLANTABLE, (PAIN RELIEF) LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 3155033

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other