BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790610 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01537
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    December 27, 2007
    Report Date
    December 28, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    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 REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. THE PROGRAM IN THE EON WHEN RETURNED COULD NOT HAVE REACHED THE PERCEPTION VALUE DUE TO IMPROPER PROGRAM SETTINGS AND WOULD NOT HAVE PROVIDED ADEQUATE STIMULATION IF PERCEPTION WAS 10.50MA AS INDICATED IN THE RETURNED IPG. IPG DID NOT FAIL TO FUNCTION CORRECTLY; WAS INCORRECTLY PROGRAMMED. SETTINGS WERE OUTSIDE THE ALLOWED VALUES BASED ON THE INFORMATION PROVIDED AND THE IPG SYSTEM CAPABILITIES INDICATED IN THE CLINICIAN MANUAL. IPG PASSED AUTOTESTING; FAILED SALINE TEST. IPG HAS DAMAGE TO THE ANTENNA AND DEEP DENTS IN THE IPG CAN. 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 PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED INADEQUATE STIMULATION SINCE RECEIVING THE SYSTEM. REPROGRAMMING DID NOT RESOLVE THE ISSUE. IN ADDITION, THE PATIENT WAS HAVING TO RECHARGE EVERY DAY IN ORDER TO MAINTAIN HER HIGH STIMULATION PARAMETERS. ON (B)(6) 2007 A LOSS OF COMMUNICATION WITH THE IPG WAS REPORTED AFTER A REPROGRAMMING SESSION. THIS COMMUNICATION LOSS LASTED ABOUT A WEEK. COMMUNICATION WAS RE-ESTABLISHED WHEN THE PHYSICIAN WENT IN TO REPLACE THE IPG ON (B)(6) 2007, HOWEVER, THE IPG DISPLAYED A "STIMULATION OFF" MESSAGE DESPITE BEING FULLY CHARGED. THE IPG WAS REPLACED AND RETURNED TO ANS FOR ANALYSIS. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    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 68318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention