BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3201832 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-15864
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 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
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES AND 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: 1627487-2013-15865. THE PATIENT REPORTED HE IS EXPERIENCING HEATING AT THE IPG SITE WHILE CHARGING. THE PATIENT STATED AFTER CHARGING IS COMPLETED HIS SKIN FEELS LIKE IT IS RAW. A REPLACEMENT LE CHARGING SYSTEM WAS SENT TO THE PATIENT. FOLLOW-UP IDENTIFIED THE PATIENT'S ISSUE WAS RESOLVED WITH THE USE OF THE REPLACEMENT CHARGING SYSTEM. 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
    290600 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3139292

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT:| SCS LEAD: MODEL 3186 (2)