BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 1265495 · Received December 16, 2008

    Report

    Report Number
    1627487-2008-00046
    Event Type
    Injury
    Date Received
    December 16, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'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. TWO MONTHS LATER, IT WAS REPORTED PATIENT WAS ADMITTED TO HOSPITAL FOR SWOLLEN IPG SITE THAT WAS TENDER TO THE TOUCH. IT WAS REPORTED HOSPITAL HAS TAKEN A CULTURE, WHICH WAS SENT OUT FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE. SYSTEM STILL IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR (IPG) LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3716 171251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other