BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4252886 · Received November 11, 2014

    Report

    Report Number
    1627487-2014-05769
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 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

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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#: 1627487-2014-05770. IT WAS REPORTED THE PATIENT EXPERIENCES POCKET HEATING WHILE RECHARGING THE IPG. IN TURN, A REPLACEMENT CHARGING SYSTEM WAS SENT TO THE PATIENT TO ADDRESS 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 WERE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726454 EON SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3716 4153409

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other SCS EXTENSIONS: MODEL (X2)| SCS LEADS: MODEL 3169 (X2)| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEADS: MODEL 3166 (X2)