BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ MRI IPG

    MDR report key: 5142133 · Received October 9, 2015

    Report

    Report Number
    1627487-2015-07579
    Event Type
    Injury
    Date Received
    October 9, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF INFECTION AT THE IPG SITE CANNOT BE CONFIRMED VIA LABORATORY TESTING. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION AT THE IPG SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671778 PROTÉGÉ MRI IPG SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3771 5107023

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other MODEL: 3228, SCS LEAD