BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS G4 IPG

    MDR report key: 1904351 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02363
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 17, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 SPECS AND NO ANOMALIES WERE FOUND. IPG WAS RETURNED WITH PART OF EXTENSION IN HEADER. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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 THEIR SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT PART OF THE LEAD WAS STUCK IN THE IPG. THE SYSTEM WAS REPLACED ON (B)(6) 2008. THE EXPLANTED IPG WAS RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS G4 IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3604 56302

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention