BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 LEAD

    MDR report key: 1880250 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-02860
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. 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

    ON (B)(6)2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED THAT APPROXIMATELY 36 HOURS LATER, THE PT COMPLAINED OF PAIN IN THE RIGHT FLANK AND UPPER CHEST WALL. THE PAIN PROGRESSIVELY BECAME WORSE EACH DAY. THE PT STATED THAT THE PAIN PERSISTED WHETHER THE STIMULATION WAS ON OR OFF. ON (B)(6)2010, THE DOCTOR TOOK AN X-RAY AND OBSERVED THAT THE LEAD HAD MIGRATED TO THE RIGHT. THE DOCTOR EXPLANTED AND REPLACED THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3244 2819743

    Patients

    Seq Age Sex Outcome Treatment
    1 Other