BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3193654 · Received June 25, 2013

    Report

    Report Number
    1627487-2013-13976
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 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

    THE PT'S SUTURES AT HER IPG SITE HAD OPENED AND THE PHYSICIAN PLANNED ON RE-CLOSING THE INCISION ON (B)(6) 2013. F/U INFO IDENTIFIED THE PT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013 AND HER SCS SYSTEM WAS EXPLANTED PER THE PT'S REQUEST. THE PT HAD STATED SHE WAS IN TOO MUCH PAIN FROM THE IMPLANT AND WANTED THE SYSTEM EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288035 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3608799

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other IMPLANT:| SCS LEAD: MODEL 3228