BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1871007 · Received October 8, 2010

    Report

    Report Number
    1627487-2010-02751
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE PRODUCT HAS NOT BEEN RETURNED SO, NO ANALYSIS COULD BE COMPLETED. 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, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT HAD AN INFECTION IN HER IPG POCKET. A CULTURE WAS TAKEN WHICH WAS POSITIVE FOR STAPH. THE CAUSE OF THE INFECTION IS UNK. THE PT WAS TREATED WITH IV VANCOMYCIN FOR 10 DAYS FOLLOWED BY ORAL ANTIBIOTICS. HER ENTIRE SYSTEM WAS EXPLANTED AND DISCARDED BUT THE DATE OF EXPLANT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3788 3117838

    Patients

    Seq Age Sex Outcome Treatment
    1 Other