BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3900160 · Received May 28, 2014

    Report

    Report Number
    1627487-2014-15398
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 6, 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 AN 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 THE PATIENT EXPERIENCES DISCOMFORT AT THE IPG SITE. THE PATIENT'S IPG IS SHALLOW AND CAUSES THE PATIENT DISCOMFORT WHEN TOUCHED. THE PATIENT CONSULTED WITH HIS PHYSICIAN WHO INDICATED THE IPG WAS IMPLANTED TO LOW. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314994 EONC SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 4204695

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR IMPLANT DATE:| SCS LEAD: MODEL 3228