BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2980214 · Received February 22, 2013

    Report

    Report Number
    1627487-2013-02272
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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

    THE PT UNDERWENT A PROCEDURE FOR AN ELECTIVE IPG REPLACEMENT. IT WAS REPORTED THE PT'S TWO EXISTING LEADS (FROM THE SAME LOT) WERE CONNECTED TO THE NEW IPG AND SHOWED HIGH IMPEDANCES. TROUBLESHOOTING IN THE OPERATING ROOM APPEARED TO RESOLVE THE ISSUE; HOWEVER, POSTOPERATIVE DIAGNOSTIC TEST REVEALED HIGH IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. REPROGRAMMING AROUND THESE LEAD CONTACTS WAS UNABLE TO PROVIDE EFFECTIVE STIMULATION. THE PHYSICIAN DECIDED TO TAKE THE PT BACK TO SURGERY. IT WAS REPORTED THE LEADS REVEALED NORMAL IMPEDANCE READING WHEN DISCONNECTED FROM THE IPG INTRAOPERATIVE. THE PHYSICIAN DRIED OFF THE LEAD ENDS AND RECONNECTED THE LEADS TO THE IPG W/O INCIDENT. POSTOPERATIVE, THE PT REPORTED EFFECTIVE STIMULATION COVERAGE AND DIAGNOSTIC TESTS REVEALED NORMAL IMPEDANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78383 OCTRODE SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3126663

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: