BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2800908 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-12300
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER WAS INCLUDED IN A FIELD CORRECTION. 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT #1627487-2012-12301. IT WAS REPORTED THE PATIENT HAD SURGERY TO RELOCATE THE IPG. REPORTEDLY, TWO DAYS POST-OPERATIVE, THE IPG SITE WAS RED, SORE, AND HOT TO THE TOUCH. IT WAS REPORTED THE PATIENT HAS A HISTORY OF (B)(6) AND PATIENT IS ON ORAL ANTIBIOTICS. FOLLOW UP DETERMINED THE PATIENT REPORTS THE IPG SITE HAS IMPROVED, BUT IS FEELING UNINTENDED STIMULATION. THE SJM REPRESENTATIVE HAS AN APPOINTMENT TO MEET WITH THE PATIENT FOR REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3706481

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention