BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD, 60CM LENGTH

    MDR report key: 2100614 · Received May 17, 2011

    Report

    Report Number
    1627487-2011-00678
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 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

    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; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. AS RECEIVED, THE LEAD WAS SEVERELY KINKED WITH ALL WIRES BROKEN APPROX 17.5 CM FROM THE STIMULATION END. THEREFORE, 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 AN SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT HE LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. UPON SURGICAL INTERVENTION, IT WAS DISCOVERED THAT THE PATIENT'S LEAD WAS FRACTURED. THE DEVICE WAS REPLACED, AND EFFECTIVE STIMULATION WAS RECAPTURED AS A RESULT. NO FURTHER COMPLICATIONS WERE REPORTED.

    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 2749486

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention IMPLANT:| SCS IPG, MODEL: 3778| IMPLANT:| SCS LEAD ANCHOR, MODEL: 1192