BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON IPG

    MDR report key: 7117593 · Received December 14, 2017

    Report

    Report Number
    1627487-2017-08371
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    November 24, 2017
    Report Date
    April 9, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2017-08372. IT WAS REPORTED (B)(6) ) THE PATIENT DID NOT CHARGED AND USED THE IPG AS RECOMMENDED AS THE PATIENT WAS NOT RECEIVING EFFECTIVE STIMULATION. REPROGRAMMING WAS TRIED MULTIPLE TIMES TO NO AVAIL. THE PHYSICIAN INDICATING THE INEFFECTIVE STIMULATION IS MAY BE DUE TO THE LEAD POSITION AS THE PHYSICIAN WAS UNABLE TO IMPLANT THE LEAD AS INTENDED DUE TO SCAR TISSUE AND PATIENT¿S ANATOMY. THE IPG WAS DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE. DEVICE INFORMATION IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2017-08372. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT UNDERWENT SUCCESSFUL TRIAL FOR DIFFERENT MODE OF THERAPY. THE IPG WAS EXPLANTED AND REPLACED WITH ANOTHER MODEL WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898831 EON IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other