BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4203314 · Received October 23, 2014

    Report

    Report Number
    1627487-2014-01671
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    June 29, 2014
    Report Date
    September 29, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 # 1627487-2014-01672. IT WAS REPORTED THE PATIENT IS EXPERIENCING UNCOMFORTABLE POCKET HEATING WHILE RECHARGING. A REPLACEMENT CHARGING SYSTEM WAS SENT. FOLLOW-UP IDENTIFIED THE REPLACEMENT CHARGER RESOLVED THE ISSUE. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, 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
    677339 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 171811

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other SCS LEAD: MODEL 3166| IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3341