BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2771968 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-06487
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: 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; 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT#: 1627487-2012-06488. THE PATIENT HAS TWO IPGS. IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO BLEEDING AT ONE OF THE IPG SITES. THE PATIENT WAS DIAGNOSED WITH A STAPH INFECTION. THE INFECTION WAS TREATED AND RESOLVED WITH THE USE OF CLINDOMYCIN AND BACTRIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3741500

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R IMPLANT:| SCS ANCHORS, MODEL: 1192 (2)| IMPLANT:| SCS LEADS, MODEL: 3186 (2)