BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3082324 · Received April 16, 2013

    Report

    Report Number
    1627487-2013-00222
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 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
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE, AND PRODUCT INTEGRITY AND FUNCTIONALITY MET THE FINAL ACCEPTANCE CRITERIA. 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

    DEVICE 5 OF 5. REFERENCE MFR. REPORTS: 1627487-2013-00147, 1627487-2013-000148, 1627487-2013-00220 AND 1627487-2013-00221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163041 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3290722

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention