BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARROW LAMITRODE TRIPOLE 16 LEAD

    MDR report key: 1604685 · Received February 5, 2010

    Report

    Report Number
    1627487-2010-00013
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 7, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOR DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBERS 1627487-2010-00043 FOR THE EVALUATION OF DEVICES 2 ). 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. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2010-00006 FOR DEVICE 1). IT WAS REPORTED THAT THE PT'S SYSTEM WAS EXPLANTED DUE TO INFECTION AT BOTH THE LEAD INSERTION SITE AND IPG POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARROW LAMITRODE TRIPOLE 16 LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3219 2782827

    Patients

    Seq Age Sex Outcome Treatment
    1 Other