BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3031974 · Received March 28, 2013

    Report

    Report Number
    1627487-2013-04385
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    December 29, 2010
    Report Date
    March 7, 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 Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL NUMBER: 1627487-07262012-001-C. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND 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: 1627487-2013-04386. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INCREASED WARMTH AT THE IPG SITE WHILE USING THE CHARGING SYSTEM. THE PATIENT WAS ADVISED OF THE CHARGING RECOMMENDATIONS TO DECREASE THE ISSUE. THE SJM REPRESENTATIVE SPOKE WITH THE PATIENT, AND A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128176 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3199510

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: