BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3141441 · Received May 24, 2013

    Report

    Report Number
    1627487-2013-13805
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    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

    THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. 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 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 WAS SEEN BY HER IMPLANTING PHYSICIAN AND THE PHYSICIAN NOTED THE PT HAD AN INFECTION AT THE IPG SITE. THE PT'S ENTIRE SCS SYSTEM WAS EXPLANTED AND SHE WAS TREATED WITH ORAL ANTIBIOTICS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232353 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3917429

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention SCS EXTENSION: MODEL 3341| IMPLANTED:| IMPLANTED:| SCS ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3286| SCS LEAD: MODEL 3166 (2)| IMPLANTED:| IMPLANTED: