BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2973557 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-02236
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN 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: 1627487-2013-02237. THE PT REC'D AN SCS SYS FOR OCCIPITAL NERVE STIMULATION (OFF-LABEL). IT WAS REPORTED THE PT COMPLAINED OF BURNING AT HER IPG SITE DURING CHARGING. A REPLACEMENT CHARGING SYS WAS SENT TO THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. ON (B)(4) 2012, ST JUDE MEDICAL, NEUROMODULATION DIV, SENT FIELD ACTION LETTERS TO PTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72667 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 57813

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention SCS EXTENSION: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3149 (4)