BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 1341653 · Received March 9, 2009

    Report

    Report Number
    1627487-2009-00006
    Event Type
    Injury
    Date Received
    March 9, 2009
    Date of Event
    January 9, 2009
    Report Date
    February 16, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOR DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2009-00007 FOR DEVICE 2 EVALUATION). METHOD: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED, NO ANOMALIES WERE FOUND. RETURNED IPG WAS VISUALLY AND PHYSICALLY INSPECTED. RESULTS: DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. IPG OPERATED ACCORDING TO SPECIFICATIONS. VISUALLY IPG HAD SOME DISCOLORATION IN THE HEADER AND AT THE UPPER SEPTUM. ANS INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2009-00007 FOR DEVICE 2). IN 2009, IT WAS REPORTED PATIENT'S SCS SYSTEM WAS EXPLANTED THE MONTH PRIOR, DUE TO AN INFECTION AT THE IPG POCKET. IT WAS REPORTED STIMULATOR WAS ERODING THROUGH THE PATIENT'S SKIN FOR THREE MONTHS BEFORE PATIENT TOLD/SAW DOCTOR. PATIENT WAS ON ANTIBIOTIC TREATMENT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR (IPG) LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 50117

    Patients

    Seq Age Sex Outcome Treatment
    1 Other