BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2800899 · Received October 18, 2012

    Report

    Report Number
    1627487-2012-11533
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    December 31, 2009
    Report Date
    September 26, 2012
    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

    EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSIONS: 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 3. REFERENCE MFR REPORT: 1627487-2012-11532, 11534. THE PT RECEIVED TWO LEADS WITH THE SAME LOT NUMBER AND TWO ANCHORS WITH THE SAME LOT NUMBER. DURING A FOLLOW UP APPOINTMENT, THE PT REPORTED TO THE SJM REPRESENTATIVE HE HAD RECEIVED AN SCS SYSTEM IN (B)(6) 2009 WHICH WAS EXPLANTED SHORTLY AFTER IMPLANT DUE TO AN INFECTION. THE PT WAS CURRENTLY IMPLANTED WITH A DIFFERENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 2867106

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention