BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3001525 · Received March 5, 2013

    Report

    Report Number
    1627487-2013-06027
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R,
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBER: 1627487-12192011-003-R, 1627487-05242011-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD CORRECTION AND FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-06028. THE PT REPORTED THAT THE CHARGER BURNS HER SKIN EVERY TIME SHE CHARGES. A NEW LOW ENERGY CHARGER WAS SENT TO THE PT TO ADDRESS THIS ISSUE. ON (B)(4) 2012, ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PT'S RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PT'S. 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
    94050 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2839908

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCS LEAD: MODEL 3225| IMPLANT DATE: