BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY MRI IPG

    MDR report key: 7736648 · Received July 31, 2018

    Report

    Report Number
    3006705815-2018-01779
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017093
    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. 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 HEALING SITE WAS IMPROVING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION GATHERED STATED THE PATIENT WAS ADMINISTERED LIFELONG ANTIBIOTICS. IN TURN, THE PATIENT WAS COLONIZED. HOWEVER, IT WAS UKNOWN IF THE ISSUE WAS DUE TO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED REDNESS AT THE IPG SITE. CULTURES WERE TAKEN AND PRESUMED POSITIVE FOR AN INFECTION. IN TURN ANTIBIOTICS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578344 PRODIGY MRI IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3772 A000053527 05415067017093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL 1192, SCS ANCHOR| MODEL 3228, SCS LEAD