BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3950165 · Received June 27, 2014

    Report

    Report Number
    1627487-2014-00392
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM HAS LIMITED INFORMATION 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 ((B)(6)) WAS WITHOUT STIMULATION DUE TO AN INOPERABLE IPG. THE IPG HAD REPORTEDLY NOT BEEN RECHARGED FOR AT LEAST 6 MONTHS DUE TO DIFFICULTIES EXPERIENCED BY THE PT WHEN ATTEMPTING TO DO SO. NO COMMUNICATION COULD BE ESTABLISHED WITH THE DEVICE USING EITHER THE CHARGING SYS OR PROGRAMMER. SURGICAL INTERVENTION WAS UNDERTAKEN TO EXPLANT AND REPLACE THE IPG. EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376695 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 2834056

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other