BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 4202034 · Received October 21, 2014

    Report

    Report Number
    1627487-2014-05720
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). SJM HAS LIMITED INFO 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

    DEVICE 1 OF 3. REF MFR REPORTS: 1627487-2014-05721, 05722. ON 09/26/2014, THE PT WAS IMPLANTED WITH AN SCS SYSTEM FOR OFF-LABEL USE. IT WAS REPORTED INVALID CONTACTS WERE PRESENT THE FOLLOWING DAY. X-RAYS WERE TAKEN AND REVEALED THE EXTENSIONS HAD PULLED OUT OF THE IPG HEADER. AS A RESULT, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014. DURING THE PROCEDURE, THE LAST CONTACT FROM ONE OF THE EXTENSIONS WAS FOUND TO BE INSIDE THE IPG HEADER. IN TURN, THE DOCTOR EXPLANTED AND REPLACED THE EXTENSIONS (WITH DIFFERENT MODELS) ALONG WITH THE IPG. OPTIMAL STIMULATION WAS RESTORED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670332 EON MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 4548174

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other SCS LEADS, MODEL: 3166 (X2)| SCS LEADS, MODEL: 3169 (X2)| IMPLANT DATE:| IMPLANT DATE: