BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3082451 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-01436
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    July 26, 2012
    Report Date
    March 26, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN 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: 1627487-2013-1437. IT WAS REPORTED, THE PATIENT IS EXPERIENCING UNCOMFORTABLE POCKET HEATING AT HIS IPG SITE WHILE CHARGING. THE PATIENT INDICATED HE CAN ONLY CHARGE FOR 15 MINUTES BEFORE THE HEAT BECOMES INTOLERABLE. A NEW LE CHARGER WAS SENT TO THE PATIENT TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163329 EON MINI SCS IPG LGW ST. JUDE MEDICAL, NEUROMODULATION 3788 3738947

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention SCS LEAD: MODEL 3228| IMPLANT DATE: