BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2894836 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-02871
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. THE INDIVIDUAL AFFECTED DEVICE WAS REMOVED FROM THE LOT. ALL OTHER DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. 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 2. REF MFR REPORT: 1627487-2012-02870. THE PT RECEIVED TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AS PART OF HER SCS SYSTEM. IT WAS REPORTED THE PT DEVELOPED AN INFECTION AT HER IPG POCKET AND LEAD SITES. THE PT'S SYSTEM WAS REMOVED ON (B)(6) 2012. IT WAS REPORTED NO CULTURES WERE TAKEN. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3814284

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention