BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS 8-CHANNEL IPG

    MDR report key: 1790800 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01348
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    February 5, 2009
    Report Date
    February 5, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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. INSUFFICIENT DATA TO CONFIRM NORMAL/EARLY BATTERY DEPLETION. 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 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 ON (B)(6) 2005. IT WAS REPORTED THAT THE IPG WAS EXPLANTED DUE TO BATTERY DEPLETION ON (B)(6) 2009. FOLLOW UP ON THE PATIENT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE IPG WAS RETURNED TO ANS FOR EVALUATION. NO PATIENT PROGRAM PARAMETERS WERE MADE AVAILABLE SO THERE WAS INSUFFICIENT DATA TO CONFIRM NORMAL OR EARLY BATTERY DEPLETION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS 8-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3608 3322AD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention