BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE

    MDR report key: 3850380 · Received May 30, 2014

    Report

    Report Number
    1627487-2014-15417
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 8, 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 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

    THE PATIENT HAS 2 LEADS (FROM THE SAME LOT) IMPLANTED AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PATIENT LOST STIMULATION. REPROGRAMMING WAS ABLE TO PROVIDE EFFECTIVE THERAPY, HOWEVER 1 HOUR AFTER REPROGRAMMING, THE PATIENT'S PROGRAMS BEGAN AUTO-REDUCING. THE SJM REPRESENTATIVE MET WITH THE PATIENT AND DIAGNOSTIC TESTING INDICATED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE THERAPY. THE PATIENT IS TO CONSULT WITH HIS PHYSICIAN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319871 OCTRODE SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3186 2743951

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other SCS IPG: MODEL 3788| IMPLANT: