BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1893240 · Received November 1, 2010

    Report

    Report Number
    1627487-2010-03083
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 4, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: A REVIEW OF THE DHR FOUND A NON-CONFORMANCE RELATED TO THE PRODUCT, HOWEVER, THE NON-CONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. 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 1 OF 3. REFERENCE MANUFACTURER REPORT: 1627487-2010-03084 AND 1627487-2010-03085. THE PT RECEIVED HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, TWO ANCHORS (OF THE SAME LOT) AND AN IPG, ON (B)(6) 2010. IT WAS REPORTED THE PT PRESENTED WITH A FEVER AND DISCHARGE FROM THE LEAD INCISION SITE. AS THE PHYSICIAN SUSPECTED AN INFECTION, THE INCISION SITE WAS CULTURED AND CLEANED. THE PRODUCT REMAINS IMPLANTED WHILE THE PHYSICIAN AWAITS THE CULTURE RESULTS. ADDITIONAL INFO REGARDING THE PT'S STATUS WAS REQUESTED BUT NOT RECEIVED. NO ADDITIONAL INFO AVAILABLE.

    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 3087472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention