BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16 CHANNEL IPG

    MDR report key: 1791910 · Received August 4, 2010

    Report

    Report Number
    1627487-2010-01951
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 22, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK FOR THIS DEVICE. 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) 2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT COULD NOT FEEL THE STIMULATION. THE SALES REP MET WITH THE PT AND WAS UNABLE TO LOCATE THE IPG WITH THE PROGRAMMER OR CHARGER. THE SALES REPRESENT ORDERED THE PT ANOTHER CHARGER. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT¿S IPG WOULD BE EXPLANTED ON (B)(6) 2010. THE SALES REP STATED THAT THE PT HAD FALLEN WHICH ULTIMATELY LED TO THE PROBLEMS WITH THE IPG.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other