BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2881104 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-06939
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 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

    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 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 PT'S SCS SYSTEM WAS EXPLANTED DUE TO THE PT HAVING A STAPH INFECTION AT THE IPG SITE. THE EXPLANT DATE IS UNK AT THIS TIME. THE INFECTION WAS RESOLVED WITH THE USE OF ORAL ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO SJM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST JUDE MEDICAL - NEUROMODULATION 3788 3772672

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD: MODEL 3219| IMPLANT:| EXPLANT: