BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1260076 · Received December 10, 2008

    Report

    Report Number
    2182207-2008-08183
    Event Type
    Injury
    Date Received
    December 10, 2008
    Report Date
    November 12, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: WOLTER T, KAUBE H, MOHADJER M. HIGH CERVICAL EPIDURAL NEUROSTIMULATION FOR CLUSTER HEADACHE: CASE REPORT AND REVIEW OF THE LITERATURE. CEPHALALGIA. 2008;28(10):1091-1094. CCH IS THE MOST SEVERE AND DISTRESSING PRIMARY HEADACHE SYNDROME. IN SOME CASES MEDICAL TREATMENT FAILS AND OPERATIVE TREATMENT OPTIONS HAVE TO BE CONSIDERED. OUR CASE, A MALE, TO OUR KNOWLEDGE, IS THE FIRST TO DESCRIBE SCS AS A TREATMENT OPTION FOR CCH. IT IS LESS INVASIVE THAN DBS, BUT MORE INVASIVE THAN ONS. IT CONSISTS OF AN APPROVED TECHNIQUE THAT CAN BE EASILY PERFORMED AND DOES NOT CARRY GREAT RISK. REPORTABLE EVENT: DUE TO ELECTRODE FAILURE (ONLY TWO OF THE FOUR ELECTRODES OF THE QUAD ELECTRODE WERE STILL WORKING) THERE HAD TO BE AN ELECTRODE REVISION FIVE MONTHS AFTER THE FIRST ELECTRODE IMPLANTATION. SEE MFR REPORT# 2182207-2008-08180.

    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 Hospitalization PROGRAMMER: MODEL UNK N=1| LEAD: MODEL UNK N=1| EXTENSION: MODEL UNK N=1