BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3326697 · Received August 27, 2013

    Report

    Report Number
    1627487-2013-19271
    Event Type
    Injury
    Date Received
    August 27, 2013
    Date of Event
    July 30, 2013
    Report Date
    July 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    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 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'S LEADS WERE EXPLANTED AND REPLACED ON (B)(6) 2013. REFERENCE MFR REPORT NUMBERS: 1627487-2013-06295, 062976, 06297. THE IPG IS NOW PROTRUDING AND CAUSES PAIN. THE PHYSICIAN REPORTED THE EXTENSION CONNECTORS WERE PLACED UNDER THE IPG DURING THE SURGERY. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418290 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3843553

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSIONS: MODEL 3343 & 3341| SCS LEADS: MODEL 3166