BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2143085 · Received June 23, 2011

    Report

    Report Number
    1627487-2011-01687
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL: THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF INFECTION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY AND STERILIZATION RECORDS FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS COSMETIC ISSUE AND DID NOT AFFECT THE PRODUCT FUNCTIONALITY OR INTEGRITY. THE DEVICE WAS, THEREFORE, APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSIONS: 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 2 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01686. THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2011. THE LEADS WERE IMPLANTED IN THE LEFT SUPRAORBITAL REGION AND LEFT CHEEK, AND THE IPG WAS IMPLANTED IN THE LEFT PECTORAL REGION. IT WAS REPORTED THAT THE PATIENT'S FACE BECAME SWOLLEN, AND IT WAS NOT PAINFUL BUT FELT WARM TO THE TOUCH. THE PHYSICIAN PRESCRIBED INTRAVENOUS ANTIBIOTICS PROPHYLACTICALLY. FOLLOW UP ON THE PATIENT FOUND THAT HE HAD DEVELOPED AN INFECTION, AND THE PHYSICIAN EXPLANTED THE SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE INFECTION WAS IN THE IPG POCKET, THE LEAD INCISION SITE AND LEAD TRACK. THE PHYSICIAN INDICATED THAT THE INFECTION LIKELY ORIGINATED AT THE PATIENT'S FACIAL WOUND. THE PATIENT IS UNDER THE CARE OF AN INFECTIOUS DISEASE PHYSICIAN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3224742

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention