BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS XP IPG

    MDR report key: 1904086 · Received October 28, 2010

    Report

    Report Number
    1627487-2010-02153
    Event Type
    Injury
    Date Received
    October 28, 2010
    Date of Event
    September 25, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 2 OF 2. EVALUATION: METHOD: 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. (B)(4). ANS HAS LIMITED INFORMATION 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

    DEVICE 2 OF 2. REFER TO MANUFACTURER REPORT 1627487-2010-2152. THE PT RECEIVED HER SCS SYSTEM ON AN UNK DATE. IT WAS REPORTED THAT THE PT WAS IN A VEHICULAR ACCIDENT AFTER WHICH IT WAS REPORTED THAT PT'S STIMULATION WAS NOT WORKING PROPERLY. THE PT COMPLAINED OF DISCOMFORT AT IPG SITE AND PRESSURE AT THE LEAD SITE WHEN THE STIMULATION WAS TURNED ON FOR 15 MINUTES. THE IPG AND LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2008. THE EXPLANTED IPG AND LEADS WERE SENT BACK TO ANS FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS XP IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3644 29477A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention