BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1260077 · Received December 10, 2008

    Report

    Report Number
    2182207-2008-08184
    Event Type
    Injury
    Date Received
    December 10, 2008
    Report Date
    November 12, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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: THREE YEARS AFTER IMPLANTATION, THERE WAS A FAILURE OF THE SYSTEM DUE TO BATTERY LOSS OF THE IMPULSE GENERATOR, WHICH LED TO AN IMMEDIATE RETURN OF THE BACKGROUND PAIN AS WELL AS THE ATTACKS. WHEN A NEW IMPULSE GENERATOR HAD BEEN IMPLANTED, THE SYSTEM WORKED AS EFFECTIVELY AS BEFORE AND THERE WAS INSTANT PAIN RELIEF. 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 Other EXTENSION: MODEL UNK N=1| PROGRAMMER: MODEL UNK N=1| LEAD: MODEL UNK N=1