BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3201798 · Received June 26, 2013

    Report

    Report Number
    1627487-2013-05912
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 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 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'S IPG WAS EXPLANTED DUE TO THE PT HAVING PAIN/DISCOMFORT AT THE IPG SITE. THE DOCTOR CUT THE LEADS AT THE IPG SITE DUE TO SCAR TISSUE IN LIEU OF EXPLANTING THE IPG. THE LEADS WILL REMAIN INSIDE THE PT. THE PT HAS BEEN DOING WELL SINCE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291359 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 2798926

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other SCS EXTENSION: MODEL 3341| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| SCS LEADS: MODEL 3156 (X2)