BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM

    MDR report key: 6535588 · Received May 1, 2017

    Report

    Report Number
    1627487-2017-02265
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    April 7, 2017
    Report Date
    December 22, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2017-002272. IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION. IT WAS STATED THE PATIENT HAS A HISTORY OF FLESH-EATING BACTERIA INFECTION. THE PATIENT IS BEING TREATED WITH ANTIBIOTICS. SUBSEQUENTLY, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION AS THE NEXT COURSE OF ACTION. PLEASE NOTE: IT IS UNKNOWN WHERE THE INFECTION IS LOCATED. THEREFORE, ALL SUSPECTED DEVICES ARE BEING REPORTED.

    Description of Event or Problem · 1

    DEVICE 1 OF 2, REFERENCE MFR. REPORT#: 1627487-2017-02272.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315360 PROCLAIM SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 5588969

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other