BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3150053 · Received May 30, 2013

    Report

    Report Number
    1627487-2013-04661
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 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

    EVAL METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: 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 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-04662, REFERENCE MFR REPORT: 1627487-2013-04669. IT WAS REPORTED THE PT HAD GONE TO THE EMERGENCY ROOM ON THE NIGHT OF (B)(6) 2013, DUE TO PAIN. IT WAS REPORTED THE PT HAD BEEN PLACED ON ANTIBIOTICS THE SAME DAY AT THE PHYSICIAN'S OFFICE APPOINTMENT. F/U IDENTIFIED THE SCS SYSTEM WAS EXPLANTED, AND THE PT'S WIFE REPORTED THE HOSP PERSONNEL TOLD HER THE PT MAY HAVE BACTERIA MENINGITIS. FURTHER F/U IDENTIFIED THE PT WAS RECEIVING HOME HEALTH CARE EACH DAY AND WAS PLACED ON IV ANTIBIOTICS. IT WAS REPORTED THE PT HAD INCREASED WELLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237702 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3971093

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R