BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC 16-CHANNEL IPG

    MDR report key: 1823424 · Received August 25, 2010

    Report

    Report Number
    1627487-2010-01933
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS 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, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, THE PT REPORTED THAT THE IPG SITE WAS RED AND SWOLLEN. THE PT SAW THE DOCTOR LAST WEEK , AND THE DOCTOR DRAINED FLUID FROM THE SITE. THE IPG INCISION SITE LATER OPENED. THE PT WAS DIRECTED TO TAKE ANTIBIOTICS AND TREAT THE SITE WITH WOUND PACKING. ON (B)(6), 2010, THE PT INFORMED THE SALES REP THAT SHE WENT TO THE EMERGENCY ROOM THE PRIOR EVENING. THE DEVICE HAS NOT BEEN EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3688 3117703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other