BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3231443 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-12932
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 18, 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
    TX, US
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT#: 1627487-2013-12933. IT WAS REPORTED THE SYSTEM DIAGNOSTICS SHOWED SEVERAL CONTACTS WITH INVALID IMPEDANCES. THE PT WAS REPROGRAMMED WITH EFFECTIVE STIMULATION. THE PT WAS ALSO EXPERIENCING DIFFICULTY CHARGING DUE TO COMMUNICATION ISSUES BETWEEN THE IPG AND CHARGER. FOLLOW-UP REVEALED THE PHYSICIAN EXPLANTED AND REPLACED THE SYSTEM. THE IPG DUE TO THE AGE AND THE LEAD DUE TO THE INVALID CONTACTS. THE PT WAS REPROGRAMMED AND IS EXPERIENCING EFFECTIVE STIMULATION PRODUCT WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323680 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 40333A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other