BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRION

    MDR report key: 3962486 · Received July 14, 2014

    Report

    Report Number
    1627487-2014-00419
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS DEVICE IS NOT APPROVED FOR SALE IN THE USA, BUT IS SIMILAR TO A USA MARKETED/APPROVED DEVICE. 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

    IT WAS REPORTED THE PATIENT (B)(6) DEVELOPED AN INFECTION AT THE IPG POCKET WHICH WAS DETECTED APPROXIMATELY TWO DAYS AFTER IMPLANT. THE PATIENT'S IPG WAS EXPLAINED AS A RESULT, AND INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AS TREATMENT. A CULTURE WAS TAKEN, BUT THE RESULTS HAVE NOT BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409252 BRION DBS IPG LGW ST. JUDE MED - NEUROMODULATION 6788 4116643

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANT DATE:| DBS EXTENSION: MODEL 6316| DBS LEAD: MODEL 6149| IMPLANT DATE: