BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3201805 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-08261
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULTION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT HAD TENDERNESS AND PAIN DIRECTLY BELOW THE IPG (IMPLANTABLE PULSE GENERATOR). THE PT WAS PRESCRIBED A MEDICATED CREAM BUT THE ISSUE DID NOT RESOLVE. THE PT WAS TO CONSULT WITH HIS PHYSICIAN TO DECIDE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289693 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULTION 3716 2881386

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other IMPLANT:| SCS LEAD: MODEL 3219