BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4172695 · Received October 13, 2014

    Report

    Report Number
    1627487-2014-15745
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFO 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# : 1627487-2014-15746. THE PATIENT REPORTED HE LOST STIMULATION AND HIS IPG IS UNABLE TO COMMUNICATE WITH THE CHARGER. THE PATIENT'S PROGRAMMER DISPLAYS A COMMUNICATION ERROR MESSAGE. ADDITIONALLY, THE PATIENT REPORTED EXPERIENCING HEATING AT THE IPG SITE WHILE CHARGING. THE SJM REP IS TO CONTACT THE PATIENT AS THE NEXT COURSE OF ACTION. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIV, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. 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
    647330 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 116852

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other SCS LEAD, MODEL: 3186| IMPLANT DATE: