BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 9848262 · Received March 18, 2020

    Report

    Report Number
    2182207-2020-00028
    Event Type
    Death
    Date Received
    March 18, 2020
    Date of Event
    February 7, 2020
    Report Date
    March 18, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE ARTICLE WAS NOT ATTACHED TO INITIAL SUBMISSION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    TORRES CV, BLASCO G, NAVAS GARCIA M, ET AL. DEEP BRAIN STIMULATION FOR AGGRESSIVENESS: LONG-TERM FOLLOW-UP AND TRACTOGRAPHY STUDY OF THE STIMULATED BRAIN AREAS. J NEUROSURG. 2020:1-10. 10.3171/2019.11.JNS192608. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENT REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: INITIAL STUDIES APPLYING DEEP BRAIN STIMULATION (DBS) OF THE POSTEROMEDIAL HYPOTHALAMUS (PMH) TO PATIENTS WITH PATHOLOGICAL AGGRESSIVENESS HAVE YIELDED ENCOURAGING RESULTS. HOWEVER, THE ANATOMICAL STRUCTURES INVOLVED IN ITS THERAPEUTIC EFFECT HAVE NOT BEEN PRECISELY IDENTIFIED. THE AUTHORS¿ OBJECTIVE WAS TO DESCRIBE THE LONG-TERM OUTCOME IN THEIR 7-PATIENT SERIES, AND THE TRACTOGRAPHY ANALYSIS OF THE VOLUMES OF TISSUE ACTIVATED IN 2 OF THE RESPONDERS. THIS WAS A RETROSPECTIVE STUDY OF 7 SUBJECTS WITH PATHOLOGICAL AGGRESSIVENESS. THE FINDINGS ON MRI WITH DIFFUSION TENSOR IMAGING (DTI) IN 2 OF THE RESPONDERS WERE ANALYZED. THE AUTHORS GENERATED VOLUMES OF TISSUE ACTIVATED ACCORDING TO THE PARAMETERS USED, AND SELECTED THOSE VOLUMES AS REGIONS OF INTEREST TO DELINEATE THE TRACTS AFFECTED BY STIMULATION. THE SERIES CONSISTED OF 5 MEN AND 2 WOMEN. OF THE 7 PATIENTS, 5 SIGNIFICANTLY IMPROVED WITH STIMULATION. THE PMH, VENTRAL TEGMENTAL AREA, DORSAL LONGITUDINAL FASCICULUS, AND MEDIAL FOREBRAIN BUNDLE SEEM TO BE INVOLVED IN THE STIMULATION FIELD. IN THIS SERIES, 5 OF 7 MEDICATION-RESISTANT PATIENTS WITH SEVERE AGGRESSIVENESS WHO WERE TREATED WITH BILATERAL PMH DBS SHOWED A SIGNIFICANT LONG-LASTING IMPROVEMENT. THE PMH, VENTRAL TEGMENTAL AREA, DORSAL LONGITUDINAL FASCICULUS, AND MEDIAL FOREBRAIN BUNDLE SEEM TO BE IN THE STIMULATION FIELD AND MIGHT BE RESPONSIBLE FOR THE THERAPEUTIC EFFECT OF DBS. REPORTED EVENTS: CASE 5 - A (B)(6) YEAR OLD FEMALE PATIENT IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) FOR PATHOLOGICAL AGGRESSIVENESS DIED DUE TO A STROKE SIX MONTHS AFTER THE DBS PROCEDURE. PAST MEDICAL HISTORY INCLUDED PERINATAL HYPOXIA AND SEVERE MENTAL RETARDATION. THE FOLLOWING DEVICE INFORMATION WAS IDENTIFIED IN THE LITERATURE ARTICLE: LEAD MODEL 3389, INS MODEL 7428.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311208 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death