BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 4380532 · Received January 5, 2015

    Report

    Report Number
    1627487-2015-10002
    Event Type
    Injury
    Date Received
    January 5, 2015
    Date of Event
    December 1, 2014
    Report Date
    June 23, 2015
    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
    OTHER

    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.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    RESULTS: CONCLUSION OCTRODE LEAD MODEL 3186 LOT# 3190337: THE REPORTED LOSS OF STIMULATION WAS CONFIRMED. THE LEAD WAS RETURNED CUT IN TWO PIECES AND COULD NOT BE FULLY ANALYZED. ALL OF THE INTERNAL WIRES IN THE STIM SEGMENT WERE BROKEN. IT COULD NOT BE DETERMINED IF THE BROKEN WIRES OCCURRED BEFORE OR DURING THE EXPLANT PROCEDURE. A REVIEW OF THE DOWNLOADED REGISTERS OF THE EXPLANTED IPG SHOWED THAT THE SETTINGS WERE AGGRESSIVE. BENCH TESTING USING A LAB EON MINI IPG ATTACHED TO A 1K OHM LOAD SHOWED AT 90HZ, 200US, THE IPG WOULD START AUTO REDUCING AT 11.8MA. THIS WAS WHILE USING 1 STIM SET. THIS IS CONSISTENT WITH THE OBSERVATIONS MADE IN THE FIELD AND WOULD EXPLAIN WHY THE PATIENT COULD NOT ACHIEVE EFFECTIVE STIMULATION. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2015-10001.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2015-10001.

    Description of Event or Problem · 1

    DEVICE 2 OF 2 REFERENCE MFR REPORT: 1627487-2015-10001

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2015-10001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3190337

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other MODEL 3788, SCS IPG, IMPLANT DATE:| MODEL 1194 (2), SCS ANCHOR, IMPLANT DATE: