BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3193627 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-15846
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RECALL NUMBERS: 1627487-07262012-002-R, 1627487-05242011-002-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: 1627487-2013-15847. THE PATIENT REPORTED HE IS EXPERIENCING HEATING AT THE IPG SITE WHILE CHARGING. A REPLACEMENT LE CHARGING SYSTEM WAS SENT TO THE PATIENT AS THE NEXT COURSE OF ACTION. 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
    288492 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2929925

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other IMPLANT:| IMPLANT:| SCS LEAD: MODEL 3186| IMPLANT:| SCS EXTENSION: MODEL 3386| IMPLANT:| SCS EXTENSION: MODEL 3346| SCS LEAD: MODEL 3186