BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1852385 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02784
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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. 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 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. PLEASE SEE MFR REPORT #1627487-2010-02726 FOR DEVICE 1. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE DOCTOR IMPLANTED TWO TRIAL LEADS. THE PT HAD GOOD STIMULATION. AFTER FIFTEEN MINUTES OF THE STIMULATION RUNNING, THE PT EXPERIENCED EXCRUCIATING PAIN DOWN HIS LEFT LEG. THE SENSATION PERSISTED AFTER THE STIMULATOR WAS TURNED OFF AND AFTER THE PT WAS GIVEN A SERIES OF PAIN MEDICATIONS INTRAVENOUSLY. THE TRIAL CABLES WERE DISCONNECTED FROM THE LEADS. AFTER FIVE HOURS, THE PAIN SUBSIDED AND THE PT WAS DISCHARGED. THE LEADS WERE STILL IMPLANTED, BUT THE PT WAS NOT USING THE STIMULATOR. THE NEXT DAY, THE DOCTOR MOVED THE LEADS DOWN SLIGHTLY. THE PT THEN HAD A SUCCESSFUL TRIAL. THE LEADS WERE TAKEN OUT AND THE PT WILL BE GETTING A PERMANENT IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 3148169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other