BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C LEAD

    MDR report key: 1800734 · Received August 12, 2010

    Report

    Report Number
    1627487-2010-01449
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    June 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. UPDATED INFO WAS ADDED ON 06/28/2010 AS A RESULT OF ANALYSIS OF THE LEAD. CHANNELS 1-5 FAILED CONTINUITY, IMPEDANCE, AND STRESS TESTING. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THE ORIGINAL COMPLAINT FOR "INEFFECTIVE STIMULATION" WAS CONFIRMED. 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

    ON (B)(6) 2007, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED THAT THE LEAD LOCATION WAS REVISED SEVERAL TIMES AND THE STIMULATION WAS NOT ACCEPTABLE TO THE PT. THE PT REQUESTED TO HAVE THE SYSTEM EXPLANTED. THE SYSTEM WAS EXPLANTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C LEAD IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3214 85722

    Patients

    Seq Age Sex Outcome Treatment
    1 Other