BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1625300 · Received March 5, 2010

    Report

    Report Number
    1627487-2010-00067
    Event Type
    Injury
    Date Received
    March 5, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 4, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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, IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT THE IPG SITE AND APPEARS TO BE TRAVELING UP THE LEAD. THE IPG SYSTEM WAS EXPLANTED AND THE PT PLACED ON IV ANTIBIOTIC THERAPY. THE DR STATED THE INFECTION WAS NON-DEVICE RELATED AND WAS STAPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2811031

    Patients

    Seq Age Sex Outcome Treatment
    1 Other