BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1790817 · Received August 4, 2010

    Report

    Report Number
    1627487-2010-01953
    Event Type
    Injury
    Date Received
    August 4, 2010
    Date of Event
    May 20, 2010
    Report Date
    June 25, 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

    EVAL: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE 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

    DEVICE 1 OF 3. PLEASE SEE MFR REPORTS # 1627487-2010-01965 AND 1627487-2010-01966 FOR DEVICES 2 AND 3. ON (B)(6)2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED THAT THE PT LOST STIMULATION AND STATED THAT THE SYSTEM WAS UNCOMFORTABLE. AN X-RAY WAS TAKEN AND REVEALED THAT THE PERCUTANEOUS LEAD WAS WRAPPED AROUND THE IPG. ON (B)(6)2010, THE DOCTOR REPLACED THE PT'S PERCUTANEOUS LEAD. ON (B)(6)2010, THE PT MET WITH THE DOCTOR FOR A ROUTINE CHECK-UP. IT WAS THEN OBSERVED THAT THE LEAD WAS DISCONNECTED FROM THE IPG AND HAD MIGRATED. THE DOCTOR BELIEVES THE PT TWIDDLED THE IPG. ON (B)(6)2010, THE PT WAS TAKEN TO THE EMERGENCY ROOM DUE TO ARM, NECK, AND HEAD PAIN. A NEUROSURGEON SAW THE PT AND DID NOT FIND ANY SIGNS OF A NEUROLOGICAL DEFICIT, BUT ADMITTED THE PT TO THE HOSPITAL. ON (B)(6)2010, THE PT WAS REVISED. DURING THE PROCEDURE, IT WAS NOTED THAT THE TERMINAL END ELECTRODE WAS MISSING FROM THE LEAD AND STUCK IN THE IPG. THE DOCTOR DECIDED TO REPLACE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 2852607

    Patients

    Seq Age Sex Outcome Treatment
    1 Other