BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 2120220 · Received June 7, 2011

    Report

    Report Number
    1627487-2011-01615
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 7, 2011
    Report Date
    May 9, 2011
    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

    MANUFACTURER'S EVALUATION: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. EVALUATION: 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. 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

    DEVICE 3 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01613 AND 1627487-2011-01614. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), AND TWO EXTENSIONS (FROM THE SAME LOT), ON (B)(6) 2011. THE LEADS WERE INSERTED OCCIPITALLY (OFF-LABEL). IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE LEAD INCISION SITE. THE PHYSICIAN CONSEQUENTLY EXPLANTED THE SYSTEM ON (B)(6) 2011. THE CULTURE RESULTS SHOWED A (B)(6), AND THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. FOLLOW UP ON THE PATIENT FOUND THAT SHE WAS DISCHARGED HOME WITH ORAL ANTIBIOTICS. THE INFECTION ALLEGEDLY HAD RESOLVED, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SPINAL CORD STIMULATION LEAD EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3136782

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R