BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3820898 · Received May 13, 2014

    Report

    Report Number
    1627487-2014-23310
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    ST. JUJDE 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 RELATED TO THIS EVENT WERE FOUND. CONCLUSION: 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 EXPERIENCED SWELLING AROUND THE IPG SITE. IT WAS ALSO REPORTED, THE PHYSICIAN'S MEDICAL ASSISTANT STATED CLEAR FLUID WAS DRAWN FROM THE SWOLLEN AREA AND SENT FOR CULTURE. THE PATIENT WAS PRESCRIBED AN ORAL ANTIBIOTIC AS A PRECAUTION. FOLLOW UP INFORMATION REVEALED THE PATIENT WAS DIAGNOSED WITH A STAPHYLOCOCCUS INFECTION AND IS CONTINUING TO TAKE THE ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287510 EON SCS IPG GZB ST. JUJDE MEDICAL - NEUROMODULATION 3716 3831934

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other IMPLANT DATE:| SCS LEAD: 3316 (2)| IMPLANT DATE:| SCS LEAD: MODEL 3346 (3)| IMPLANT DATE:| SCS LEAD: MODEL 3169 (2)