BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2969382 · Received February 20, 2013

    Report

    Report Number
    3007566237-2013-00542
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    October 28, 2012
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONTINUATION OF CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD: SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4). THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS PAIN RELIEF.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MESSINA, G., RIZZI, M., CORDELLA, R., CARACENI, A., ZECCA, E., BUSSONE, G., FRANZINI, A., LEONE, M. SECONDARY CHRONIC CLUSTER HEADACHE TREATED BY POSTERIOR HYPOTHALAMIC DEEP BRAIN STIMULATION: FIRST REPORTED CASE. CEPHALALGIA: AN INTERNATIONAL JOURNAL OF HEADACHE. 2013;33(2):136-138. DOI: 10.1177/0333102412468675. SUMMARY: DEEP BRAIN STIMULATION (DBS) OF THE POSTERIOR HYPOTHALAMUS (PHYP) HAS BEEN REPORTED AS AN EFFECTIVE TREATMENT FOR PRIMARY, DRUG-REFRACTORY AND CHRONIC CLUSTER HEADACHE (CCH). WE HERE DESCRIBE THE USE OF SUCH A PROCEDURE FOR THE TREATMENT OF SECONDARY CCH DUE TO A NEOPLASM AFFECTING THE SOFT TISSUES OF THE RIGHT HEMIFACE. A (B)(6) MAN AFFECTED BY INFILTRATING ANGIOMYOLIPOMA OF THE RIGHT HEMIFACE WHO SUBSEQUENTLY DEVELOPED DRUG REFRACTORY HOMOLATERAL CCH UNDERWENT DBS OF THE RIGHT PHYP REGION AT THE (B)(4). AFTER SURGERY, THE PATIENT PRESENTED A SIGNIFICANT REDUCTION IN FREQUENCY OF PAIN BOUTS. HOWEVER, BECAUSE OF A SUBSEQUENT INFECTION, THE ENTIRE SYSTEM WAS REMOVED. AFTER RE-IMPLANTATION OF THE SYSTEM, SUCCESSFUL OUTCOME WAS OBSERVED AT 2 YEARS FOLLOW-UP. THIS BRIEF REPORT SHOWS THE FEASIBILITY OF PHYP DBS IN SECONDARY DRUG-REFRACTORY CCH SYNDROMES; FUTURE REPORTS ARE NEEDED IN ORDER TO CONFIRM OUR POSITIVE RESULT. REPORTED EVENT: A (B)(6) MALE EXPERIENCED A GRADUAL LOSS OF ADEQUATE PAIN RELIEF. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STIMULATION WAS INCREASED. FOLLOWING REPROGRAMMING, THE INTENSITY OF THE PATIENT'S PAIN ATTACKS BEGAN TO REDUCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73734 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Hospitalization