BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3820957 · Received May 8, 2014

    Report

    Report Number
    1627487-2014-01301
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 17, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PATIENT REC'D TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PATIENT IS EXPERIENCING INTERMITTENT STIMULATION. F/U REVEALED IMPEDANCES ARE WITHIN NORMAL LIMITS. REPROGRAMMING WAS PERFORMED AND NEW PROGRAMS GIVEN ON (B)(6) 2014; HOWEVER THE ISSUE REOCCURRED ON (B)(6) 2014. STIMULATION HAS BEEN TURNED OFF AND X-RAYS WERE ORDERED. THE PATIENT WILL F/U WITH HER PHYSICIAN AT A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279935 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL, NEUROMODULATION 3189 3641713

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788