BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790885 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01189
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 13, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 SPECS AND NO ANOMALIES WERE FOUND. THE IPG AS RETURNED WAS NOT COMMUNICATING AND WAS NOT FUNCTIONAL. THE BATTERY WAS DEPLETED PAST THE POINT WHERE IT COULD BE RECHARGED. FOLLOWING RECHARGING, THE IPG BATTERY WAS DEPLETING AT A NORMAL RATE. 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 HER SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2008. THE PT WAS RECHARGING THE SYSTEM ABOUT EVERY TWO WEEKS UNTIL AROUND (B)(6) 2010, WHEN SHE REALIZED SHE WAS NEEDING TO RECHARGE EVERY 4 DAYS. REPROGRAMMING WAS PERFORMED WHICH WORKED FOR ABOUT A MONTH UNTIL THE PT TURNED THE SYSTEM OFF FOR SURGERY ON HER FOOT. FOLLOWING THE SURGERY SHE WAS UNABLE TO TURN THE SYSTEM ON AGAIN. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2010. THE EXPLANTED IPG WAS RETURNED TO ANS ON (B)(6) 2010. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3788 173071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention