BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3161519 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-04700
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 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 INFORMATION 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 HAD AN INFECTION AT THE IPG SITE. THE PT MET WITH THE IMPLANTING PHYSICIAN AND WAS PLACED ON ANTIBIOTICS. IT WAS REPORTED THE IPG AREA HAD IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249480 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3866040

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3183| SCS LEAD: MODEL 3245