BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2432034 · Received January 30, 2012

    Report

    Report Number
    3007566237-2012-00199
    Event Type
    Injury
    Date Received
    January 30, 2012
    Report Date
    January 2, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED: UNK, EXPLANTED: UNK, EXTENSION: MODEL NEU_UNKNOWN_EXT, LOT# UNKNOWN, SERIAL# UNKNOWN.

    Description of Event or Problem · 1

    LITERATURE: MULLER, O. M., GAUL, C., KATSARAVA, Z., SURE, U., DIENER, H.-C., GASSER, T. BILATERAL OCCIPITAL NERVE STIMULATION FOR THE TREATMENT OF CHRONIC CLUSTER HEADACHE: CASE SERIES AND INITIATION OF A PROSPECTIVE STUDY. FORTSCHR NEUROT PSYCHIAT 2010; 78: 709-714. DOI: 10.1055/S-0029-1245599. SUMMARY: THE AUTHORS REPORT ON THE EFFICACY OF BILATERAL OCCIPITAL NERVE STIMULATION (ONS) FOR PATIENTS WITH CHRONIC CLUSTER HEADACHE (CCH). BETWEEN (B)(6) 2008 AND (B)(6) 2009 SEVEN PATIENTS WITH THERAPY-REFRACTORY CCH WERE TREATED WITH BILATERAL ONS. THE FOLLOW-UP OF THE PATIENTS LASTED AN AVERAGE OF 12 MONTHS. OVERALL, THE INTENSITY OF THE ATTACKS DECREASED BY 50% AND THE CONSUMPTION OF ATTACK MEDICATION WAS REDUCED BY 77%. A TENDENCY TOWARDS IMPROVED QUALITY OF LIFE WAS SEEN IN ALL PATIENTS BY MEANS OF A STANDARDIZED QUESTIONNAIRE (SF-36). REPORTED EVENTS: ONE PATIENT EXPERIENCED AN INFECTION AT THE GENERATOR SITE WHICH MADE A TRANSIENT EXTERNALIZATION OF THE ELECTRODES AND IMPLANTATION OF A NEW GENERATOR AFTER INFECTION CLEAN-UP NECESSARY. THIS LED TO A UNILATERAL ELECTRODE DISLOCATION WITHOUT IMPAIRING THE DISTRIBUTION OF THE STIMULATION. THE PATIENT HAS SINCE BEEN SYMPTOM-FREE IN THIS RESPECT AND CONTINUES TO SPEAK WELL OF THE ONS. SCAR FORMATIONS REQUIRED RE-OPERATION AND ADHESIOLYSIS OF THE THORACIC CONNECTOR IN ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL#