BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1870556 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02202
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 7, 2007
    Report Date
    December 10, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: 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 3. REFERENCE MFR REPORT: 1627487-2010-02203 & 1627487-2010-02204. THE PT REC'D HER SCS SYSTEM CONSISTING OF TWO PERCUTANEOUS LEADS AND AN IPG ON (B)(6)2007. IT WAS REPORTED BOTH LEADS HAD MIGRATED LATERALLY. IN ADDITION, THE PT COMPLAINED OF PAIN AT THE IPG SITE DUE TO ITS PLACEMENT. WHILE THE IPG IMPLANT POCKET WAS BEING REVISED, THE SURGICAL TECHNICIAN IMMERSED THE IPG IN STERILE SALINE BUT NEGLECTED TO PLUG THE IPG HEADER PORTS. AS A RESULT, A NEW IPG HAD TO BE IMPLANTED. THE LEADS WERE REPOSITIONED AND RE-ANCHORED. SHORTLY AFTER THE PROCEDURE, THE PT REPORTED THAT STIMULATION WAS NOT COVERING HER PAIN. BOTH LEADS WERE EXPLANTED AND REPLACED. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED. ONLY THE IPG WAS RETURNED TO THE MFR ANALYSIS. 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 83992

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention