BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1586988 · Received January 15, 2010

    Report

    Report Number
    1627487-2009-00199
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 16, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: 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 EVENT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    ON (B) (6) 2009, IT WAS REPORTED THAT THE PATIENT COULD NOT RECHARGE THE IPG BATTERY AND THAT A DIFFERENT CHARGING SYSTEMS WAS TRIED WITH THE SAME RESULTS. IT WAS REPORTED THAT THE PATIENT CHARGED FOR SEVERAL HOURS, BUT THE PATIENT PROGRAMMER STILL DISPLAYS "IPG BATTERY LOW - STIM OFF". PATIENT SUBSEQUENTLY LOST STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3788 2789907

    Patients

    Seq Age Sex Outcome Treatment
    1 Other