BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790689 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01670
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    September 5, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 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 TWO PERCUTANEOUS LEADS, AN EXTENSION AND AN IPG ON (B)(6) 2007. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) /2007 REPORTING THE DEVICE CHARGER WOULD NO LONGER COMMUNICATE WITH HER IPG. AN X-RAY OF THE PATIENT'S SYSTEM REVEALED THE IPG HAD FLIPPED IN THE IMPLANT POCKET SITE; SUBSEQUENTLY PREVENTING COMMUNICATION WITH ANY PROGRAMMER OR CHARGING SYSTEM. THE PHYSICIAN SURGICALLY REPOSITIONED THE DEVICE ON (B)(6) 2007. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO DEVICES WERE EXPLANTED AND RETURNED TO NMD 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 LGW ADVANCED NEUROMODULATION SYSTEMS 3716 69189

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention