BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE

    MDR report key: 4202670 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-15781
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 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

    SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S PHYSICIAN SUSPECTED AN INFECTION WAS PRESENT AT THE PT'S IPG SITE. THE PHYSICIAN SUSPECTED A SUTURE ABSCESS WAS PRESENT AND PRESCRIBED THE PT KEFLEX. F/U INFO REVEALED THE PHYSICIAN INDICATED THE IPG SITE LOOKS BETTER, BUT THE WOUND IS STILL OPEN. THE PT IS TO CONTINUE F/U VISITS WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673825 PROTEGE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3789 4671194

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3183 (2)