BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 7643163 · Received June 27, 2018

    Report

    Report Number
    1627487-2018-06026
    Event Type
    Injury
    Date Received
    June 27, 2018
    Report Date
    July 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
    FL, 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

    DEVICE 1 OF 3 . REFERENCE MFR. REPORT# 3006705815-2018-01491. REFERENCE MFR. REPORT# 3006705815-2018-01492. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR. REPORT# 3006705815-2018-01491. REFERENCE MFR. REPORT# 3006705815-2018-01492. IT WAS REPORTED THE PATIENT EXPERIENCED A POSSIBLE INFECTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, HOWEVER THE CULTURES PRESUMED NEGATIVE FOR AN INFECTION. IN TURN, THE SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484571 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3660 6337355 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization