BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843435 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-02664
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    THE PATIENT WAS SCHEDULED TO UNDERGO AN IPG REPLACEMENT PROCEDURE (REFERENCE MFR REPORT #1627487-2012-06270). IT WAS REPORTED THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM AND A PERIPHERAL IV NEEDLE WAS PLACED IN THE PATIENT'S HAND. IT WAS REPORTED PRIOR TO THE PATIENT RECEIVING ANY MEDICINE THROUGH THE IV, IT WAS DISCOVERED THE WRONG IPG MODEL WAS BROUGHT TO THE CASE. THE PROCEDURE ALLEGEDLY WAS ABORTED AND WILL BE RESCHEDULED AT A LATER DATE. THE DEVICE REPORTED IS THE INCORRECT MODEL THAT WAS BROUGHT TO THE CASE; THE DEVICE WAS NOT IMPLANTED NOR WAS IT OPENED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention IMPLANT:| SCS EXTENSION: MODEL 3342| IMPLANT:| SCS IPG: MODEL 3716| IMPLANT:| SCS LEAD: MODEL 3166 (2)| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1194 (3)| SCS LEAD: MODEL 3186