BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1892410 · Received November 3, 2010

    Report

    Report Number
    3007566237-2010-08789
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    July 28, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTABLE NEUROSTIMULATOR AND LEADS HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LAST MONTH, THE PATIENT CAME TO THE HOSPITAL BECAUSE OF A LOSS OF STIMULATION. IMPEDANCE READINGS WERE >4000 OHMS. A DECISION TO REVISE THE DEVICE WAS MADE. DURING THE PROCEDURE IMPEDANCES WERE ALL >10,000 OHMS AND IT WAS DISCOVERED THAT THE LEAD WAS COMPLETELY BROKEN INTO TWO PARTS, "EXCLUDING A MALFUNCTION OF THE STIMULATOR." THE STIMULATOR, LEAD AND EXTENSION WERE REMOVED. A NEW LEAD WAS INTRODUCED, BUT ITS IMPEDANCE READINGS WERE ALL >10,000 OHMS EVEN IF THE LEAD CONFIGURATION, CURRENT VALUES, AND ALL CABLES WERE CHANGED (SNAP-LID, EXTENSIONS). THE LEAD WAS REMOVED AND A THIRD LEAD WAS USED. ALL IMPEDANCES WERE CORRECT AND THE LEAD WAS IMPLANTED. THE PATIENT OUTCOME WAS REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC NEUROMODULATION 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# B0917578K| LEAD: MODEL 3587A, LOT# UNKNOWN| EXPLANTED:| LEAD: MODEL 3587A, LOT# B0917578K| LEAD: MODEL 3587A, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| IMPLANTED: