BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3231502 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-00391
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    IT WAS REPORTED SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S (B)(6) IPG DUE TO THE DEVICE REACHING ITS END OF LIFE. THE IPG HAD ONLY BEEN IMPLANTED FOR ONE YEAR. BASED ON THE PROGRAM SETTINGS PROVIDED, THIS ISSUE IS INDICATIVE OF PREMATURE BATTERY DEPLETION. THE PT REPORTEDLY LOST STIMULATION PRIOR TO THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323694 EONC SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3688 3486308

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention