BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 4202551 · Received October 22, 2014

    Report

    Report Number
    1627487-2014-21679
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 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
    AS
    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 ((B)(6)) RECEIVED TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT RECEIVED INEFFECTIVE STIMULATION. DIAGNOSTICS INDICATED MULTIPLE INVALID IMPEDANCE VALUES. REPROGRAMMING WAS UNSUCCESSFUL AS LEFT LEG STIMULATION COULD NOT BE ACHIEVED. X-RAYS DID NOT REVEAL ANY ANOMALIES. SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673595 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 4086339

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCS IPG: MODEL 3788| IMPLANT DATE: