BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2792030 · Received October 12, 2012

    Report

    Report Number
    1627487-2012-02490
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 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

    EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. 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 REPORTS: 1627487-2012-02491 AND 1627487-2012-02492. IT WAS REPORTED, THE PT HAD SIGNS OF INFECTION AT HER CERVICAL LEAD SITE AND IT APPEARED TO BE TRACKING DOWN TO THE IPG. THE PHYSICIAN REMOVED THE LEAD BUT LEFT THE IPG IMPLANTED AFTER HE IRRIGATED AND CULTURED THE POCKET SITE. IT WAS REPORTED, THE PHYSICIAN WILL LEAVE THE IPG IMPLANTED UNLESS THE IPG SITE CULTURE RESULTS ARE POSITIVE. THE PT WAS ADMITTED TO THE HOSPITAL FOR THE INTRAVENOUS ANTIBIOTICS AND PAIN CONTROL. F/U ON THE PT FOUND THE PT HAD COMPLETED ANTIBIOTIC TREATMENT AND THE INFECTION HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3612445

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention