BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY IPG

    MDR report key: 6932357 · Received October 9, 2017

    Report

    Report Number
    1627487-2017-05870
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 9, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. 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 ((B)(6)) THE PATIENT EXPERIENCED A FALL AT THE IPG SITE. IN TURN, THE IPG SITE WAS BRUISED AND HAD OPENED. THE IPG APPEARED TO BE ERODING THROUGH THE SKIN. THE PHYSICIAN REPORTED THE IPG SITE APPEARED TO BE INFECTED WITH VISIBLE PUS. CONSEQUENTLY, THE SCS SYSTEM WAS EXPLANTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710412 PRODIGY IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3799 4902760

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other