BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3052365 · Received April 3, 2013

    Report

    Report Number
    1627487-2013-13500
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED, THE PATIENT HAD GONE TO THE EMERGENCY ROOM ON (B)(6) 2013 AND AGAIN ON (B)(6) 2013 FOR WHAT SHE DESCRIBED AS SECOND AND THIRD DEGREE BURNS OVER HER IPG POCKET SITE. FOLLOW-UP INFORMATION IDENTIFIED THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN ON (B)(6) 2013. THE PATIENT HAD FAILED TO KEEP APPOINTMENTS PRIOR TO HER (B)(6) 2013 APPOINTMENT. IT WAS NOTED, THE PATIENT DID NOT WANT TO BE SEEN BY A SJM REPRESENTATIVE. IT WAS ALSO NOTED, THE HEATING WAS NOT ASSOCIATED WITH CHARGING. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135623 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3790461

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3288