BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON C

    MDR report key: 1260091 · Received December 10, 2008

    Report

    Report Number
    1627487-2008-00044
    Event Type
    Injury
    Date Received
    December 10, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. 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

    PATIENT WAS IMPLANTED WITH SCS SYSTEM IN 2008. THE FOLLOWING MONTH, IT WAS REPORTED PATIENT WAS EXPERIENCING SKIN IRRITATION AND PAIN AT IPG POCKET SITE. PHYSICIAN EXPLANTED SYSTEM AND SENT TISSUE SAMPLE TO PATHOLOGY FOR ANALYSIS. IN ADDITION, IT WAS REPORTED PHYSICIAN SUSPECTS' PATIENT MIGHT HAVE AN ALLERGY TO DEVICE. THROUGH FOLLOW-UP, IT WAS REPORTED PATIENT IS DOING FINE AND TISSUE SAMPLE CAME BACK WITH NO EVIDENCE OF AN INFECTION. IT WAS REPORTED THAT A LATER DATE PHYSICIAN PLANS TO PERFORM ALLERGY TESTS AND THEN REIMPLANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON C IMLPANTABLE PULSE GENERATOR (IPG) GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3688 173624

    Patients

    Seq Age Sex Outcome Treatment
    1 Other