BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052250 · Received April 4, 2013

    Report

    Report Number
    1627487-2013-13510
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 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
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG MODEL WAS ASSOCIATED WITH 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: 1627487-2013-13511. THE PATIENT REPORTED, SHE EXPERIENCED POCKET HEATING WHILE CHARGING HER SCS SYSTEM. THE PATIENT STATED, SHE HAS EXPERIENCED THIS EVER SINCE SHE WAS IMPLANTED. THE PATIENT DESCRIBED IT AS "BURNING" AND AFTER SHE COMPLETED CHARGING, SHE WOULD HAVE TO RUB OINTMENT OVER THE BURNS AT HER IPG POCKET SITE. THE PATIENT ALSO STATED, SHE QUIT CHARGING HER SYSTEM IN (B)(6) 2012 DUE TO THE BURNING WHILE CHARGING. THE PATIENT COULDN'T RECALL IF SHE TURNED HER SYSTEM OFF OR LET IT DEPLETE ON IT'S OWN. FOLLOW-UP PENDING. 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
    137590 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3755776

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| SCS LEAD, MODEL 3228