BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790654 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01500
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    July 23, 2007
    Report Date
    August 1, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. 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 RECEIVED HIS SYSTEM CONSISTING OF 4 PERCUTANEOUS LEADS IN THE OCCIPITAL (OFF-LABEL LOCATION) AND CERVICAL AREAS AND AN IPG ON (B)(6) 2007. IT WAS REPORTED THAT THE PT RECHARGED THE IPG FOR THE FIRST TIME ON (B)(6) 2007 WITHOUT INCIDENT. ON (B)(6) 2007, THE PT REPORTEDLY USED THE PROGRAMMER TO COMMUNICATE WITH THE IPG AND EXPERIENCED A BURNING SENSATION AT THE IPG SITE. THIS REPORTEDLY HAPPENED AGAIN ON (B)(6) 2007 WHEN THE DEVICE WAS INTERROGATED IN THE PHYSICIAN'S OFFICE. A REPLACEMENT PROGRAMMER WAND DID NOT RESOLVE THE ISSUE. AN X-RAY CONFIRMED THAT ALL CONNECTIONS WERE INTACT. THE BURNING SENSATION ALSO REPORTEDLY OCCURRED DURING RECHARGING AS WELL. THE IPG WAS EXPLANTED IN (B)(6) 2007 AND RETURNED TO ANS FOR ANALYSIS.

    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 83257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention