BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3961027 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-23482
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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 THAT PATIENT'S IPG POCKET SITE WAS LOCATED IN HIS LEFT BUTTOCK AND WHEN SITTING, HE EXPERIENCED DISCOMFORT. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014, WHERE HIS IPG POCKET SITE WAS RELOCATED TO THE LEFT FLANK AREA. THE PHYSICIAN ELECTIVELY REMOVED THE IPG AND REPLACED IT WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429181 EON MINI SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3788 3776222

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE: