BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44 LEAD

    MDR report key: 1852357 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02602
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT LOST STIMULATION. THE SALES REP MET WITH THE PT AND OBSERVED INVALID IMPEDANCE ON TWO CONTACTS. THE REP ATTEMPTED TO REPROGRAM THE PT, BUT WAS UNABLE TO ACHIEVE ADEQUATE STIMULATION USING THE REMAINING CONTACTS. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT HAD FALLEN 3 TIMES AND HER LEADS SUBSEQUENTLY MIGRATED. THE LEADS WERE EXPLANTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44 LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3262 3104023

    Patients

    Seq Age Sex Outcome Treatment
    1 Other