BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3012194 · Received March 13, 2013

    Report

    Report Number
    1627487-2013-15354
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN FIELD ADVISORIES. 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

    THE PATIENT REPORTED TWO WEEKS AFTER HIS SCS SYSTEM WAS IMPLANTED, "SPOTS" BROKE OUT AROUND HIS IPG INCISION. THE PHYSICIAN CLEANED OUT THE POCKET SITE. ONE WEEK LATER THE "SPOTS" WERE STILL PRESENT AND THE STITCHES WERE NOT HOLDING THE INCISION CLOSED. THE PHYSICIAN REMOVED THE IPG, CLEANED OUT THE POCKET SITE AND RE-IMPLANTED THE IPG. THE PATIENT INDICATES AFTER THE SECOND TIME THE POCKET SITE WAS CLEANED HE WAS ADMITTED TO ICU FOR 14 DAYS. AFTER THE PATIENT WAS DISCHARGED, THE PHYSICIAN EXPLANTED THE IPG. FOLLOW-UP INFORMATION INDICATED THE INFECTION IS RESOLVED AND THE PATIENT MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106618 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3249779

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R IMPLANT DATE:| SCS LEAD: MODEL 3228