BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1852427 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02729
    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
    NY, 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. CONCLUSIONS - 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 2. PLEASE SEE MFR REPORT #1627487-2010-02822 FOR DEVICE 2. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYS. THE DOCTOR IMPLANTED TWO TRIAL LEADS. THE PT HAD GOOD STIMULATION INTRAOPERATIVELY. ABOUT FIFTEEN MINS AFTER THE PT'S SYS WITH PROGRAMMED, THE PT COMPLAINED OF CHEST PRESSURE. THE STIMULATOR WAS TURNED OFF, BUT THE CHEST PRESSURE PERSISTED. THE PT WAS GIVEN MEDICATION AND THE CHEST PRESSURE STILL PERSISTED. A TWO-LEAD EKG SHOWED NORMAL CARDIAC BEHAVIOR, BUT AN AMBULANCE WAS CALLED. THE RESCUE TEAM TOOK A TWELVE-LEAD EKG WHICH ALSO SHOWED NORMAL CARDIAC BEHAVIOR. THE RESCUE TEAM ELECTED TO TAKE THE PT TO THE HOSPITAL. THE PT WAS CLEARED TO HAVE HIS SYS PROGRAMMED ON THE SAME DAY. THE PT DID WELL THROUGH THE PROGRAMMING SESSION. HE HAD NOT SUFFERED A HEART ATTACK. HE DID VERY WELL THROUGH HIS TRIAL. THE DOCTOR IS RECOMMENDING HIM FOR A DUAL SYS IMPLANTATION.

    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 3126602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization