BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 4240519 · Received October 30, 2014

    Report

    Report Number
    1627487-2014-26910
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    ST. JUDE MED - 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
    IL, 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 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:1627487-2014-26911. THE PATIENT REPORTS HE EXPERIENCED THE CHARGING SYSTEM BECOMING WARM DURING RECHARGING WHICH CAUSED A LITTLE DISCOMFORT IN HIS BACK. A REPLACEMENT MODEL 3726 CHARGING SYSTEM WAS SENT TO THE PATIENT. 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
    697090 EON SCS IPG GZB ST. JUDE MED - NEUROMODULATION 3716 83499

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3816