BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 5507653 · Received March 17, 2016

    Report

    Report Number
    1627487-2016-01270
    Event Type
    Injury
    Date Received
    March 17, 2016
    Report Date
    June 15, 2016
    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

    (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. (B)(4).

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2016-01269. IT WAS REPORTED THE PATIENT RECEIVES INEFFECTIVE STIMULATION THERAPY. AN SJM REPRESENTATIVE INTERROGATED THE SYSTEM AND FOUND HIGH IMPEDANCES ON SEVERAL CONTACTS. REPROGRAMMING WAS ONLY ABLE TO PROVIDE STIMULATION IN PART OF HER PAIN PATTERN. IMAGES WERE TAKEN BUT SHOWED NO ANOMALIES. SURGICAL INTERVENTION MAY BE TAKEN TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR REPORT #1627487-2016-012769. NOTE: ONE LEAD WAS EXPLANTED AND REPLACED. IT IS UNKNOWN WHICH LEAD WAS EXPLANTED THEREFORE BOTH LEADS ARE BEING REPORTED AS EXPLANTED. IT WAS REPORTED ONE OF THE LEADS WAS EXPLANTED AND REPLACED ON (B)(6) 2016. THE PATIENT REPORTEDLY RECEIVED EFFECTIVE STIMULATION FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165028 OCTRODE LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 3219025

    Patients

    Seq Age Sex Outcome Treatment
    1 Other