BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960176 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-12496
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 1 OF 2. REFERENCE MFR REPORT #1627487-2014-12497. IT WAS REPORTED THE PT EXPERIENCED DECREASED PAIN RELIEF I HIS ANKLE AND FOOT FOLLOWING AN INJURY TO THE AREA. AN SJM REPRESENTATIVE INTERROGATED THE SYSTEM AND FOUND NO ANOMALIES. THE PHYSICIAN DISCONNECTED THE EXISTING LEAD (DEVICE 1) ON (B)(6) 2014 AND ADDED A NEW LEAD (DEVICE 2). POST OPERATIVE PROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE STIMULATION COVERAGE. THE PHYSICIAN THEN EXPLANTED BOTH THE LEADS, AND IMPLANTED A NEW OCTRODE LEAD. PATIENT REPORTED RECEIVING PARTIAL COVERAGE WITH THE NEW LEAD. THE NEXT COURSE OF ACTION IS REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429902 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3787864

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR IMPLANTED:| SCS EXTENSION: MODEL 3341| SCS LEAD: MODEL 3143 (2)| SCS IPG: MODEL 3788| IMPLANTED:| IMPLANTED: