BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3010548 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-01277
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    November 8, 2012
    Report Date
    February 20, 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
    OTHER

    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 # 1627487-2013-1278. IT WAS REPORTED THE PT HAS EXPERIENCED INTENSE HEAT AT HER IPG SITE DURING CHARGING SINCE HER SCS SYSTEM IMPLANT. A NEW LE CHARGER WAS SENT TO THE PT TO ADDRESS THE ISSUE. IT WAS ALSO REPORTED THE PT IS EXPERIENCING DISCOMFORT AT HER IPG SITE. THE PT'S IPG IS SUPERFICIAL DUE TO WEIGHT LOSS. THE PT WAS ADVISED TO CONSULT HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108557 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3803857

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention IMPLANT DATE:| SCS LEAD: MODEL 3219| SCS ANCHOR: MODEL 1192| IMPLANT DATE: