BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE IPG

    MDR report key: 3950481 · Received July 10, 2014

    Report

    Report Number
    1627487-2014-05486
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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, THE PATIENT'S IPG SITE WAS PAINFUL, HOT TO THE TOUCH, AND DISCOLORED. THE PATIENT ALSO EXPERIENCED A FEVER OF 100, CHILLS, AND A "HORRIBLE" HEADACHE. AS A RESULT, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014. WHILE HOSPITALIZED THE PATIENT'S WHITE BLOOD COUNT WAS FOUND TO BE HIGH. IN TURN, THE PATIENT'S SCS SYSTEM WAS EXPLANTED DUE TO CULTURE RESULTS SHOWING (B)(6). ON (B)(6) 2014. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. SHE WILL BE ON CIPRO AND RIFAMPIN TO ADDRESS THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403935 PROTEGE IPG SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3789 4584801

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization IMPLANT DATE:| SCS ANCHORS, MODEL: 1192 (X2)| SCS LEADS, MODEL: 3186 (X2)| IMPLANT DATE: