BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1823395 · Received August 25, 2010

    Report

    Report Number
    1627487-2010-02423
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 27, 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
    CA, 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 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 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

    ON (B)(6)2010, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE PATIENT'S HUSBAND CALLED THE REPRESENTATIVE AND SAID THAT THE LAST TWO TIMES HIS WIFE HAD TURNED ON HER SCS SYSTEM, SHE WOULD GET RELIEF FOR HER HEADACHES, BUT SHE WOULD HAVE A SEIZURE. THE PATIENT HAS A HISTORY OF SEIZURES. THEY HAVE INCREASED IN FREQUENCY OVER THE YEARS. SHE IS UNDER THE CARE OF A NEUROLOGIST. HER PHYSICIANS DO NOT FEEL THE DEVICE IS RELATED TO THE SEIZURES. ALTHOUGH SOME PAIN MEDICINES ARE ALSO USED FOR ANTI-SEIZURE MEDICATION, THE PATIENT HAS HAD NO CHANGE IN HER MEDICATIONS. THE REPRESENTATIVE DID REPORT THAT THE HUSBAND HAS OBSERVED THAT WHILE THE PATIENT DOES HAS SEIZURES MORE FREQUENTLY (WITH OR WITHOUT THE DEVICE IN USE), SHE DOES HAVE A REACTION EACH TIME THE DEVICE IS TURNED ON.

    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 2878008

    Patients

    Seq Age Sex Outcome Treatment
    1 Other