BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1860373 · Received September 24, 2010

    Report

    Report Number
    1627487-2010-02534
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    July 15, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK. 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

    IT WAS REPORTED THAT THE PT'S IPG LOST COMMUNICATION WITH THE CHARGER. THE SALES REPRESENTATIVE SENT THE PT 3 CHARGERS BUT NONE COULD ESTABLISH COMMUNICATION WITH THE DEVICE. AN X-RAY WAS TAKEN AND DID NOT REVEAL ANY ANOMALIES. THE PT HAS NOT HAD AN MRI OR ANY OTHER MEDICAL TESTS. IT IS CURRENTLY UNK WHAT THE NEXT COURSE OF ACTION WILL BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3716

    Patients

    Seq Age Sex Outcome Treatment
    1 Other