BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16-CHANNEL IPG

    MDR report key: 1960429 · Received December 16, 2010

    Report

    Report Number
    1627487-2010-03939
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    June 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SJM NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HIS SCS SYSTEM ON (B)(6) 2007. ON (B)(6) 2010, IT WAS REPORTED THAT THE MAGNET OPTION HAD NOT BEEN WORKING FOR THE PAST 6 MONTHS. A COMPANY REPRESENTATIVE VERIFIED THAT THE MAGNET OPTION WAS ON BUT THE IPG DID NOT RESPOND TO THE MAGNET. A NEW MAGNET WAS SHIPPED TO THE CUSTOMER. THE PATIENT REPORTED THAT THE NEW MAGNET DID NOT WORK EITHER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR REPORTED EVENTS HAVE OCCASIONALLY RESULTED IN THE EXPLANTS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW SJM NEUROMODULATION DIVISION 3716 85244

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention