BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 2871559 · Received October 29, 2012

    Report

    Report Number
    1627487-2012-02588
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    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 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 RECEIVED TWO PERCUTANEOUS LEADS (FROM THE SAME LOT) AS PART OF HIS SCS SYSTEM. THE PT UNDERWENT SURGERY FOR AN IPG REPLACEMENT ON (B)(6) 2012 (REFERENCE MFR REPORT #1627487-2012-12247). IT WAS REPORTED INTRAOPERATIVE TESTING REVEALED INVALID IMPEDANCE READINGS ON ALL LEAD CONTACTS FOR ONE LEAD AND INVALID/HIGH IMPEDANCE READINGS FOR THE OTHER LEAD. THE LEADS WERE DISCONNECTED FROM THE IPG AND EXHIBITED THE SAME VALUES WHEN RETESTED. THE PHYSICIAN ALLEGEDLY DISCONNECTED THE LEAD WITH INVALID CONTACTS FROM THE IPG BUT LEFT THE DEVICE IMPLANTED. A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE IPG AND NO LEADS WERE EXPLANTED. IT WAS REPORTED THE CASE WAS EXTENDED BY ONE HOUR DUE TO THE ISSUE. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3094680

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| SCS IPG: MODEL 3788| IMPLANT DATE: