BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1910249 · Received November 18, 2010

    Report

    Report Number
    1627487-2010-03290
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE 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. THE LEADS WERE RETURNED INCOMPLETE. AS SUCH, NO FUNCTIONAL TESTING COULD BE PERFORMED. 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

    THE PATIENT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS FROM THE SAME LOT ON (B)(6) 2009. IT WAS REPORTED THAT HE LOST STIMULATION. DIAGNOSTIC TESTS YIELDED HIGH IMPEDANCE READINGS FOR THE SYSTEM. AN X-RAY WAS TAKEN WHICH SHOWED A POSSIBLE LEAD FRACTURE. THE LEADS WERE REMOVED AND REPLACED (B)(6) 2010 AND EFFECTIVE STIMULATION WAS RECAPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL- NEUROMODULATION DIV 3186 2865481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention