BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 7785757 · Received August 15, 2018

    Report

    Report Number
    1627487-2018-07556
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    July 24, 2018
    Report Date
    October 23, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020192
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. MANUFACTURER 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. MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED. REPORTEDLY, THE PATIENT WAS ADMINISTERED ANTIBIOTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A POSSIBLE INFECTION LOCATED AT THE IPG INCISION SITE. REPORTEDLY THE PATIENT IPG SITE WAS NOT HEALED AND THE PHYSICIAN SUSPECTED A INFECTION. IN TURN THE IPG SITE WAS PRESUMED A POSSIBLE INFECTION. SURGICAL INTERVENTION MAY OCCUR LATER TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626146 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3660 6388747 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192 (2), SCS ANCHORS| MODEL 3186 (2), SCS LEADS