BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IPG

    MDR report key: 1790633 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01516
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    September 29, 2009
    Report Date
    October 2, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT WAS EXPERIENCING STIMULATION IN UNINTENDED AREAS AND THAT THE PT FELT STIMULATION EVEN WHEN THE IPG WAS TURNED OFF. THE PHYSICIAN EXPLANTED THE IPG. IT WAS REPORTED THAT FOLLOWING THE EXPLANT PROCEDURE, THE PT CONTINUED TO EXPERIENCE THE TINGLING SENSATIONS AND IT WAS POSSIBLE SHE HAD A NERVOUS SYSTEM DISORDER CAUSING HER TO FEEL ELECTRICAL IMPULSES. IT WAS REPORTED THAT THE PT MAY RECEIVE ANOTHER SCS SYSTEM IN THE FUTURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE EXPLANTED IPG WAS NOT RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 57027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention