BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3123484 · Received May 17, 2013

    Report

    Report Number
    1627487-2013-04612
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    October 26, 2012
    Report Date
    April 26, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-12192011-003-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. SJM 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD NOT CHARGED THE IPG NOR HAD STIMULATION FOR 6 MONTHS. THE SJM REP MET WITH THE PT AND CONFIRMED THE IPG WAS NONRESPONSIVE. IT WAS REPORTED THE PT WANTED TO HAVE THE IPG REPLACED. FOLLOW-UP IDENTIFIED THE PHYSICIAN REPLACED THE IPG. IT WAS REPORTED THE SYSTEM WAS FUNCTIONING POSTOPERATIVE AND THE PT RECEIVED EFFECTIVE STIMULATION COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219557 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3308486

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)