BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2903052 · Received January 3, 2013

    Report

    Report Number
    1627487-2013-02010
    Event Type
    Injury
    Date Received
    January 3, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION/REMOVAL REPORTING NUMBER: 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

    REFERENCE MFR REPORTS: 1627487-2013-02011. THE PATIENT HAS 2 SCS SYSTEMS. IT WAS REPORTED THE PATIENT EXPERIENCES IPG POCKET HEATING WHEN SHE CHARGES HER THORACIC IP. SHE STATED THE ISSUE STARTED (B)(6) AGO AND SHE TRIED CHARGING MORE FREQUENTLY FOR LESS TIME. THE SJM REPRESENTATIVE PLANS TO MEET WITH THE PATIENT TO ADDRESS THE ISSUE. ON (B)(4) 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
    2046 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3121735

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANT DATE:| SCS LEAD: MODEL 3224 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| SCS EXTENSION: MODEL 3383 (2)| IMPLANT DATE: