BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS 8-CHANNEL IPG

    MDR report key: 1800749 · Received August 12, 2010

    Report

    Report Number
    1627487-2010-01422
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. DEVICE SETTINGS WERE EXAMINED TO DETERMINE IF THE CAUSE WAS NORMAL BATTERY DEPLETION. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. NORMAL BATTERY DEPLETION COULD NOT BE CONFIRMED. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    ON (B)(6)2005, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE IPG REACHED ITS END OF LIFE AND THE PT RECEIVED AN IPG REVISION. IPG WAS EXPLANTED ON (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS 8-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3608 35520B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other