BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3110786 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02641
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A 1627487-12192011-003-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. 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: 1627487-2013-02642. IT WAS REPORTED THE PATIENT EXPERIENCES A CRAMPING PAIN RIGHT ABOVE WHERE HER IPG IS LOCATED. SHE ALSO REPORTED POCKET HEATING WHILE CHARGING. SHE STATED THE HEATING SENSATION AROUND HER IPG SITE BECOMES EXTREMELY UNCOMFORTABLE AND REQUIRES HER TO TAKE A BREAK FROM CHARGING. A NEW LE CHARGING SYSTEM WAS SENT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. 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
    204806 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3308526

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention SCS LEAD, MODEL 3246 (2)| IMPLANT DATE: UNK