BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EONC 16-CHANNEL IPG

    MDR report key: 1812444 · Received August 17, 2010

    Report

    Report Number
    1627487-2010-01996
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 13, 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
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK. 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, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT'S IPG BATTERY WAS LOW AND THE DEVICE WAS NOT COMMUNICATING WITH PT PROGRAMMER. ACCORDING TO THE SALES REP'S CALCULATIONS, THE DEVICE SHOULD HAVE LASTED FOR 71 MONTHS. THE IPG WILL BE REPLACED AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC 16-CHANNEL IPG IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other