BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790595 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01535
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    November 19, 2007
    Report Date
    November 19, 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

    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. IPG AS RETURNED WAS NONFUNCTIONAL. 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 AN IPG AND A PADDLE LEAD ON (B)(6) 2007. THE PATIENT WAS RECHARGING THE IPG EVERY DAY FOR 20 MINUTES. IT WAS REPORTED THAT THE PATIENT BEGAN EXPERIENCING DIFFICULTY CHARGING IN (B)(6) OF 2007. THE PATIENT PROGRAMMER COMMUNICATED WITH THE IPG WITHOUT INCIDENT BUT THE CHARGER WOULD NOT COMMUNICATE PROPERLY. A REPLACEMENT CHARGER DID NOT RESOLVE THE ISSUE. THE PATIENT ALSO REPORTEDLY COMPLAINED OF A BURNING SENSATION AT THE IPG SITE. IT WAS DISCOVERED THAT THE IPG HAD FLIPPED. THE IPG WAS REMOVED IN (B)(6) OF 2008 AND RETURNED TO ANS FOR ANALYSIS. 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 66916

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention