BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1834124 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-01654
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    February 11, 2010
    Report Date
    February 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED 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. 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 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

    THE PT WAS IMPLANTED WITH AN SCS SYSTEM ON (B)(6)2010. APPROX 2 WEEKS AFTER THE IMPLANT PROCEDURE, THE PT REPORTED FEELING SOMETHING "POP" FOLLOWED BY OVERSTIMULATION AND HEATING OF THE IPG POCKET. IN ADDITION, THE PT REPORTED THAT THE IPG BEGAN TURNING ITSELF OFF UP TO EIGHT TIMES PER DAY. THE IPG WAS EXPLANTED AND REPLACED. AFTER THE PROCEDURE, THE PATIENT WAS REPORTEDLY DOING WELL. THE STIMULATION WAS TESTED AND THE ABSENCE OF ANY HEATING OR OVERSTIMULATION SENSATIONS WERE VERIFIED. THE EXPLANTED IPG WAS RETAINED BY THE FACILITY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3716 2757141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention