BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3960169 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-08134
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    THE PT HAS TWO MODEL 3186 LEADS FROM THE SAME LOT. IT WAS REPORTED THE PT IS EXPERIENCING AUTO-REDUCING AND INVALID IMPEDANCES FROM HIS SCS SYSTEM BEGINNING ON (B)(6) 2014. AN SJM REPRESENTATIVE MET WITH THE PT AND REPROGRAMMED HIS SYSTEM FOR EFFECTIVE COVERAGE ON (B)(6) 2014. ON (B)(6) 2014, AN SJM REPRESENTATIVE MET WITH THE PT FOR REPROGRAMMING DUE TO ADDITIONAL INVALID IMPEDANCES AND WAS ABLE TO PROGRAM FOR EFFECTIVE STIMULATION. FLUORO OF THE PATIENT'S SYSTEM REVEALED THE LEAD HAD MIGRATED. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429945 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4046632

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other IMPLANTED:| SCS ANCHOR: MODEL 1192 (X2)| SCS IPG: MODEL 3788| IMPLANTED: