BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2446890 · Received February 12, 2012

    Report

    Report Number
    3007566237-2012-00293
    Event Type
    Injury
    Date Received
    February 12, 2012
    Date of Event
    June 5, 2011
    Report Date
    January 18, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: SEIJO F, SAIZ A, LOZANO B, ET AL. NEUROMODULATION OF THE POSTEROLATERAL HYPOTHALAMUS FOR THE TREATMENT OF CHRONIC REFRACTORY CLUSTER HEADACHE: EXPERIENCE IN FIVE PATIENTS WITH A MODIFIED ANATOMICAL TARGET. CEPHALALGIA. 2011;31(16):1634-1641. DOI: 10. 1177/033310241130264. SUMMARY: THIS ARTICLE REPORTS THE LONG-TERM OUTCOMES OF DEEP BRAIN STIMULATION OF A MODIFIED POSTEROLATERAL ANATOMICAL TARGET IN FIVE PATIENTS WITH REFRACTORY CHRONIC CLUSTER HEADACHE (CCH). THE NEW TARGET AVOIDED THE LATERAL VENTRICLE WALL SO AS TO EXTEND THE STIMULATED BRAIN AREA AND DECREASE THE MORBIDITY OF POTENTIAL HEMORRHAGIC COMPLICATIONS. ALL OF THE PATIENTS SUFFERED FROM MULTIPLE DAILY ATTACKS FOR MORE THAN TWO YEARS. ALL PATIENTS BECAME PAIN FREE IMMEDIATELY AFTER SURGERY EVEN WITH THE STIMULATOR NOT IN OPERATION, AND AFTER A TRANSIENT PERIOD OF EFFICACY OF UP TO TWO WEEKS, NEEDED REPETITIVE ADJUSTMENTS TO OPTIMIZE STIMULATION PARAMETERS AND MAINTAIN A PROLONGED EFFECT. RESULTS SHOWED THAT AFTER AN AVERAGE FOLLOW-UP OF 33 MONTHS, TWO PATIENTS REMAINED PAIN FREE, TWO HAD >90% DECREASE IN ATTACK FREQUENCY AND ONE HAD A 50% REDUCTION IN ATTACKS. THE AUTHORS CONCLUDED THAT STIMULATION OF THE MODIFIED TARGET WAS EFFECTIVE IN VERY REFRACTORY CCH. REPORTABLE EVENT: PATIENT 1, A (B)(6) FEMALE, EXPERIENCED FOR THE FIRST TIME TWO TYPICAL CLUSTER HEADACHE ATTACKS ON THE CONTRALATERAL SIDE FOR A FEW DAYS JUST AFTER THE IMPLANTATION PROCEDURE. AFTER 18 MONTHS, THE PATIENT EXPERIENCED A REAPPEARANCE OF SEVERAL DAILY CLUSTER HEADACHE ATTACKS. AN X-RAY SHOWED A RUPTURE OF THE INTRACEREBRAL ELECTRODE. THE ELECTRODE WAS REPLACED AND THE HEADACHES RESOLVED. AT THE PATIENT'S LAST FOLLOW-UP AT 38 MONTHS, THE FREQUENCY OF THE PATIENT'S ATTACKS AND THE NEED OF SUBCUTANEOUS SUMATRIPTAN DECREASED >90%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention LEAD MODEL 3389 LOT# UNK SERIAL# UNK