BEUDAMED
    FDA Adverse Event Other Summary report: N

    OCTRODE TRIAL PERCUTANEOUS LEAD

    MDR report key: 1508113 · Received October 6, 2009

    Report

    Report Number
    1627487-2009-00044
    Event Type
    Other
    Date Received
    October 6, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 16, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED 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

    ANS RECEIVED A REPORT ON (B) (6) 2009, THAT WHEN THE MD ADVANCED THE TRIAL PERCUTANEOUS LEAD TO T4 THE PT REPORTED PAIN IN THEIR BACK. IT WAS REPORTED THE PT EXPERIENCED A DROP IN BLOOD PRESSURE, A DROP IN HEART RATE, AND CHEST PAIN. THE PHYSICIAN ABORTED THE PROCEDURE, REMOVED THE LEAD, AND THE PT WAS TRANSPORTED BY AMBULANCE TO AN ER. THE PT EXPERIENCED CHEST PAINS THREE WEEKS PRIOR TO THE PROCEDURE BUT DID NOT HAVE THE PAINS CHECKED OR ADVISE THE IMPLANTING SURGEON. THE MD PLANS TO REIMPLANT THE PT AT A LATER DATE. BASED ON INFO RECEIVED FROM THE SALES REP ON (B) (6) 2009, THE PT WAS NOT ADMITTED TO THE HOSPITAL. THE PT WAS SENT HOME FROM THE ER WITH A FOLLOW-UP STRESS TEST SCHEDULED. THE LEAD WAS DISCARDED AND WILL NOT BE RETURNED TO ANS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE TRIAL PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 2825262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other