BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3193610 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-10209
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    January 6, 2012
    Report Date
    June 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S RECHARGE BURDEN HAD INCREASED RESULTING IN THE NEED TO CHARGE THE IPG DAILY ((B)(6)). THE DEVICE STOPPED WORKING IN (B)(6) 2012, AT WHICH TIME COMMUNICATION COULD NO LONGER BE ESTABLISHED BETWEEN THE IPG AND EXTERNAL DEVICE (CHARGING SYSTEM AND PT PROGRAMMER). THE IPG WAS EXPLANTED AND REPLACED WHICH RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288429 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 113956

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other