BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2133580 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-00837
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS CORRECTED AND THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE REPORTED EVENT. 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 2 OF 3. REFERENCE MFR REPORT #S: 1627487-2011-00836 AND 1627487-2011-00838. THE PT'S (B)(6) SCS SYSTEM CONSISTS OF AN IPG, PERCUTANEOUS LEAD AND LEAD EXTENSION. IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION AT THE POCKET SITE. THE IPG WAS REPORTEDLY REMOVED, STERILIZED IN ISOBETADINE FOR 30 MINS AND REIMPLANTED AT A NEW POCKET SITE. ANTIBIOTICS HAVE BEEN ADMINISTERED TO THE PT AS TREATMENT FOR THE INFECTION AND A SUBSEQUENT CULTURE HAS CONFIRMED THAT NO NEW OR RECURRING INFECTION IS PRESENT. ALL COMPONENTS OF THE PT'S SCS SYSTEM REMAIN IMPLANTED. THE MFR HAS ADVISED THAT THE REPORTED RECOURSE TAKEN IN THIS MATTER IS NOT RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3088703

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention