BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT 60CM LENGTH

    MDR report key: 1940424 · Received December 20, 2010

    Report

    Report Number
    1627487-2010-03822
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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

    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. AS RECEIVED, THE LEAD WAS SEVERELY KINKED WITH ALL WIRES BROKEN APPROXIMATELY 21CM FROM THE STIMULATION END. 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 RECEIVED HER SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT HER PERCUTANEOUS LEAD WAS REPLACED WITH A PADDLE LEAD DUE TO LEAD FRACTURE. THE EXPLANTED DEVICE WAS 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 2760261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention