BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON - IPG

    MDR report key: 1821522 · Received August 27, 2010

    Report

    Report Number
    1627487-2010-01823
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 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

    EVALUATION: 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)2007, THE PATIENT WAS IMPLANTED WITH AN SCS SYSTEM. THE PATIENT STATES THAT THERE IS NO IPG COMMUNICATION WITH CHARGER. THE PATIENT PROGRAMMER WILL LOCATE THE IPG. THE PATIENT PROGRAMMER GIVES "SYSTEM ERROR 2340 CALL ANS." THE PATIENT TURNED OFF THE IPG ABOUT A MONTH AGO. THE PATIENT WAS NOT BEEN ABLE TO TURN IT BACK ON SINCE IT COULD NOT COMMUNICATE WITH THEIR PATIENT PROGRAMMER. THE IPG WAS EXPLANTED ON (B)(6)2010 AND REPLACED WITH A NEW IPG. STIMULATION WAS CAPTURED AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON - IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716 83469

    Patients

    Seq Age Sex Outcome Treatment
    1 Other