BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2871457 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-02760
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 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

    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 TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PATIENT HAD INEFFECTIVE STIMULATION COVERAGE. THE PHYSICIAN TOOK THE PATIENT TO SURGERY AND IMPLANTED A SURGICAL LEAD AND SECOND IPG ON (B)(6) 2012. THE PATIENT'S PERCUTANEOUS LEADS REMAIN IMPLANTED. NO FURTHER INFORMATION 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 3153200

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3716