BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2921639 · Received January 10, 2013

    Report

    Report Number
    1627487-2013-02071
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 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: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. THE INDIVIDUAL AFFECTED DEVICE WAS REMOVED FORM THE LOT. ALL OTHER DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 DEVELOPED AN INFECTION AT HIS IPG POCKET SITE. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND WAS HOSPITALIZED. A CULTURE WAS TAKEN BUT THE RESULTS WERE NEGATIVE. FOLLOW-UP IDENTIFIED THE PATIENT HAD A SEROMA OR HEMATOMA AT THE IPG SITE THAT WOULD NOT HEAL. THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE ON (B)(6)012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13963 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3866016

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS LEAD: MODEL 3286| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| IMPLANT DATE: