BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1944769 · Received December 15, 2010

    Report

    Report Number
    1627487-2010-04063
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ST. JUDE MEDICAL -NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: VISUAL ANALYSIS OF THE RETURNED LEAD WAS PERFORMED. THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. A COMPLETE LEAD WAS RETURNED TO THE MFR. THE LEAD WAS RETURNED WITH ALL WIRES BROKEN APPROX 20 CM FROM THE STIMULATION END. IN ADDITION, SOME DISCOLORATION WAS OBSERVED IN THE LEAD SEGMENT. DUE TO THE BROKEN WIRES WITHIN THE LEAD, 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. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVALUATION OF OUR MDR REVIEW PROCESS. 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

    THE PT RECEIVED HIS SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2007. IT WAS REPORTED THE PT LOST STIMULATION AFTER A FALL. DIAGNOSTIC TESTING OF THE LEAD FOUND INVALID IMPEDANCE READINGS ON CONTACTS ONE THROUGH EIGHT. AS THE PHYSICIAN SUSPECTED A FRACTURE, THE LEAD WAS EXPLANTED AND REPLACED. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    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 68484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention