BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1834100 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-01742
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    October 17, 2009
    Report Date
    November 1, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2010-01743. THE PT (BELGIUM) RECEIVED AN SCS SYSTEM INCLUDING AN IPG, LEAD, AND LEAD EXTENSION ON (B)(6)2009. IT WAS REPORTED THE PT PRESENTED TO THE EMERGENCY ROOM WITH AN EXTREME BURNING SENSATION AT HIS IPG IMPLANT SITE AFTER RECHARGING HIS IPG. THE PHYSICIAN WAS ABLE TO RECREATE THE SENSATION IN THE OFFICE WHILE CHARGING THE PT'S IPG. THE PHYSICIAN WAS UNABLE TO DETERMINE ROOT CAUSE FOR THE ALLEGED HEATING SENSATION AND SCHEDULED AN EXPLORATORY SURGICAL PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN NOTED A VISUAL TEAR IN THE LEAD BODY INSULATION OF THE LEAD EXTENSION. BOTH THE LEAD EXTENSION AND DEVICE WERE EXPLANTED AND REPLACED ON (B)(6)2009. THE EXPLANTED DEVICES WERE RETURNED TO THE MFR FOR EVAL. NO ADD'L 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 171251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention