BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 1940675 · Received December 22, 2010

    Report

    Report Number
    1627487-2010-03885
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. VISUAL INSPECTION OF THE LEAD FOUND THAT THE CHANNEL 1 ELECTRODE WAS MISSING AND THERE WAS SEPARATION BETWEEN THE SPACERS AND ELECTRODES AT THE TERMINAL END. THE LEAD WAS SEVERELY KINKED WITH ALL WIRES BROKEN APPROX 14.5 CM FROM THE STIMULATION END. AS A RESULT, NO FUNCTIONAL TESTING WAS 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 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 2. REFERENCE MFR REPORT # 1627487-2010-03884. THE PT REC'D HER SCS SYSTEM ON (B)(6) 2009 CONSISTING OF AN IPG AND PERCUTANEOUS LEAD. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT'S LEAD WAS REPLACED DUE TO FRACTURE. DURING THE SURGICAL PROCEDURE, THE PHYSICIAN NOTICED THAT THE SCREW PORT OF THE IPG CONTAINED FLUID PREVENTING COMPLETE ADVANCEMENT OF THE NEW LEAD INTO THE IPG'S HEADER PORT. AS A RESULT, THE PT'S IPG WAS ALSO REPLACED. THE EXPLANTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 2765396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention