BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE TRIAL LEAD

    MDR report key: 1823420 · Received August 25, 2010

    Report

    Report Number
    1627487-2010-01970
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 29, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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 OR 2 (SEE MFG # 1627487-2010-02490). ON (B)(6)2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT EXPERIENCED INEFFECTIVE STIMULATION DURING THE PROGRAMMING OF THE DEVICE DURING IMPLANTATION. IT WAS DECIDED TO REMOVE THE LEADS. WHEN THE NURSE REMOVED THE LEADS, THE PT BLED PROFUSELY AND THE BLOOD WAS PUMPING, LIKE THERE WAS AN ARTERIAL BLEED. THE DOCTOR HELD PRESSURE OVER THE AREA FOR APPROX 10-20 MINUTES AND THE BLEEDING STOPPED. AFTER LAYING FLAT FOR APPROX AN HOUR, THE PT WAS FINE, WALKED ON HIS OWN, AND LEFT FOR HOME. A PHYSICIAN WAS CONSULTED AND THEY STATED THAT IT SOUNDED LIKE THE PT HAD A "SKIN PUMPER," WHICH WOULD NOT BE NOTICED DURING THE SCS IMPLANTATION PROCEDURE, BECAUSE THE LOCAL ANESTHETIC WOULD HAVE TAMPONADED THE ARTERY WITH LOCAL PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL LEAD PERCUTANEOUS LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 3121618

    Patients

    Seq Age Sex Outcome Treatment
    1 Other