BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1834094 · Received September 13, 2010

    Report

    Report Number
    1627487-2010-01703
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    October 1, 2008
    Report Date
    October 2, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS 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 (B)(6) RECEIVED HIS SCS SYSTEM ON (B)(6)2008. IT WAS REPORTED THAT ONE MONTH POST-IMPLANT, THE IPG CEASED TO COMMUNICATE WITH THE PT PROGRAMMER. THE PT ALSO REPORTED EXPERIENCING OVERSTIMULATION WHILE ATTEMPTING TO COMMUNICATE WITH THE IPG. THE PHYSICIAN RECOMMENDED TO REPLACE THE IPG. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO COMMUNICATE WITH THE DEVICE WHILE THE DEVICE WAS BOTH IN AND OUT OF THE POCKET. ALL ATTEMPTS WERE UNSUCCESSFUL. THE IPG WAS EXPLANTED AND REPLACED ON (B)(6)2008. NO ADDITIONAL INFO IS AVAILABLE. THE EXPLANTED IPG WAS RETURNED TO THE MFR FOR EVAL.

    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 119204

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention