BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3231536 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-10229
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, 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

    DEVICE 1 OF 2. REF MFR REPORT: 1627487-2013-10230. THE PT (POLAND) WAS IMPLANTED WITH AN SCS SYSTEM WHICH INCLUDED A LEAD AND TWO LEAD EXTENSIONS (FROM THE SAME LOT). IT WAS REPORTED THE PT RETURNED TO THE HOSP ONE WEEK FOLLOWING IMPLANT DUE TO A HIGH FEVER. THE PT WAS DIAGNOSED WITH AN INFECTION AT THE LOCATION OF THE LEAD EXTENSIONS. THE LEAD AND LEAD EXTENSIONS WERE EXPLANTED AND THE PT WAS TREATED WITH IV ANTIBIOTIC THERAPY. F/U INFO REVEALED THE PT HAS SINCE BEEN DISCHARGED FROM THE HOSP, IS AFEBRILE AND FEELING GOOD. IT WAS NOTED THAT CULTURE RESULTS RETURNED POSITIVE FOR STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324744 SINGLE EXTENSION SCS LEAD EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION 3386 3980831

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R