BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790679 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01658
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    August 9, 2007
    Report Date
    August 9, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 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 DAYS 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 CONSISTING OF A SURGICAL LEAD AND AN IPG ON (B)(6)2007. IN (B)(6)2007, THE PATIENT REPORTED SHE WAS NOT RECEIVING STIMULATION FROM THE IPG. USING HER PROGRAMMER, SHE VERIFIED THE DEVICE INDICATED STIMULATION WAS OFF. AFTER RECHARGING THE IPG, THE STIMULATION RESUMED. A FEW DAYS LATER, THE PATIENT REPORTED SHE HAD LOST STIMULATION ONCE AGAIN; HOWEVER, THIS TIME SHE WAS NOT ABLE TO COMMUNICATE WITH THE IPG WITH EITHER THE PATIENT PROGRAMMER OR THE DEVICE CHARGER. EXAMINATION OF THE PATIENT FOUND THE DEVICE POCKET TO BE VERY LARGE. AN X-RAY REVEALED THE PATIENT'S DEVICE HAD FLIPPED MAKING CONTACT WITH THE DEVICE IMPOSSIBLE. THE PHYSICIAN INDICATED THE DEVICE WOULD BE SURGICALLY REPOSITIONED. NO DEVICES WERE RETURNED TO ANS FOR EVALUATION. 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 GZB ADVANCED NEUROMODULATION SYSTEMS 3716 67523

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention