BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEADS

    MDR report key: 1880263 · Received October 19, 2010

    Report

    Report Number
    1627487-2010-03057
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 5, 2010
    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

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: A REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT, 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. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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

    DEVICE 2 OF 3. REFERENCE MFR REPORTS: 1627487-2010-03056 AND 1627487-2010-03058. THE PT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2008. IT WAS REPORTED THE DEVICE WAS EXPLANTED DUE TO AN ACCUMULATION OF FLUID AROUND THE IPG IMPLANT SITE. THE PHYSICIAN SUSPECT AN ALLERGIC REACTION OR POSSIBLE INFECTION. INTERNAL CULTURES OF THE IPG IMPLANT SITE WERE TAKEN; HOWEVER, THE RESULTS WERE NOT IMMEDIATELY AVAILABLE. THE EXPLANTED PRODUCT WAS NOT RETURNED TO THE MFR FOR ANALYSIS. F/U ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEADS TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION 3186 174303

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention