BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3110947 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-15609
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    February 12, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    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

    THE PT REPORTED HIS IPG SITE IS HOT FOR APPROX 2 HOURS AFTER CHARGING. THE PT TURNS THE STIMULATION OFF UNTIL THE BURNING SENSATION SUBSIDES AND THEN TURNS IT BACK ON. THE SJM REP MET WITH THE PT AND THE PT STATED THE BURNING/HEATING SENSATION IS FELT MOSTLY AFTER CHARGING, BUT SOMETIMES OCCURS WHEN HE HAS NOT BEEN CHARGING. ALSO, REDNESS AND A CALLUS WERE NOTED AT THE IPG SITE. THE PHYSICIAN RECOMMENDED THE PT LEAVE THE STIMULATION ON, AS IT HELPS WITH THE PT'S PAIN. ADDITIONALLY, THE PHYSICIAN INDICATED HE FEARS WITHOUT THE STIMULATION ON THE PT MAY DEVELOP GANGRENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202207 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3145874

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1194 (2)| SCS ANCHOR, MODEL 1194 (2)| SCS IPG, MODEL 3788| SCS LEAD, MODEL 3186 (2)| SCS LEAD, MODEL 3189 (2)| SCS IPG, MODEL 3788| IMPLANT DATE:| SCS LEAD, MODEL 3186 (2)| IMPLANT DATE:| SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR, MODEL 1194 (2)| SCS LEAD, MODEL 3189 (2)| IMPLANT DATE: