BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 3335291 · Received September 9, 2013

    Report

    Report Number
    3007566237-2013-02927
    Event Type
    Death
    Date Received
    September 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    August 21, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. 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. PRODUCT ID: 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    TORRES, C.V., SOLA, R.G., PASTOR, J., PEDROSA, M., NAVAS, M., GARCÍA-NAVARRETE, E., EZQUIAGA, E., GARCÍA-CAMBA, E. LONG-TERM RESULTS OF POSTEROMEDIAL HYPOTHALAMIC DEEP BRAIN STIMULATION FOR PATIENTS WITH RESISTANT AGGRESSIVENESS. JOURNAL OF NEUROSURGERY. 2013;119(2):277-287. DOI: 10.3171/2013.4.JNS121639 SUMMARY: ERETHISM DESCRIBES SEVERE CASES OF UNPROVOKED AGGRESSIVE BEHAVIOR, USUALLY ASSOCIATED WITH SOME DEGREE OF MENTAL IMPAIRMENT AND GROSS BRAIN DAMAGE. THE ETIOLOGY CAN BE EPILEPTIC, POSTENCEPHALITIC, OR POSTTRAUMATIC, OR THE CONDITION CAN BE CAUSED BY BRAIN MALFORMATIONS OR PERINATAL INSULTS. ERETHISM IS OFTEN REFRACTORY TO MEDICATION, AND PATIENTS MUST OFTEN BE INTERNED IN INSTITUTIONS, WHERE THEY ARE MANAGED WITH MAJOR RESTRAINING MEASURES. THE HYPOTHALAMUS IS A CRUCIAL GROUP OF NUCLEI THAT COORDINATE BEHAVIORAL AND AUTONOMIC RESPONSES AND PLAY A CENTRAL ROLE IN THE CONTROL OF AGGRESSIVE BEHAVIOR. DEEP BRAIN STIMULATION (DBS) OF THE POSTEROMEDIAL HYPOTHALAMUS (PMH) HAS BEEN PROPOSED AS A TREATMENT FOR RESISTANT ERETHISM, ALTHOUGH EXPERIENCE WITH THIS TREATMENT AROUND THE WORLD IS SCARCE. THE OBJECTIVE OF THIS STUDY WAS TO EXAMINE THE LONG-TERM OUTCOME OF PMH DBS IN 6 PATIENTS WITH SEVERE ERETHISM TREATED AT THE AUTHORS¿ INSTITUTION. MEDICAL RECORDS OF 6 PATIENTS TREATED WITH PMH DBS FOR INTRACTABLE AGGRESSIVENESS WERE REVIEWED. THE THERAPEUTIC EFFECT ON BEHAVIOR WAS ASSESSED BY THE INVENTORY FOR CLIENT AND AGENCY PLANNING PREOPERATIVELY AND AT THE LAST FOLLOW-UP VISIT. TWO PATIENTS DIED DURING THE FOLLOW-UP PERIOD DUE TO CAUSES UNRELATED TO THE NEUROSURGICAL TREATMENT. FIVE OF 6 PATIENTS EXPERIENCED A SIGNIFICANT REDUCTION IN AGGRESSIVENESS (THE MEAN INVENTORY FOR CLIENT AND AGENCY PLANNING GENERAL AGGRESSIVENESS SCORE WAS -47 AT BASELINE AND -25 AT THE LAST FOLLOW-UP; MEAN FOLLOW-UP 3.5 YEARS). SIMILAR RESPONSES WERE OBTAINED WITH LOW- AND HIGH-FREQUENCY STIMULATION. IN 4 CASES, THE PATIENTS¿ SLEEP PATTERNS BECAME MORE REGULAR, AND IN 1 CASE, BINGE EATING AND POLYDIPSIA CEASED. ONE OF THE 3 PATIENTS WHO HAD EPILEPSY NOTICED A 30% REDUCTION IN SEIZURE FREQUENCY. ANOTHER PATIENT EXPERIENCED A MARKED SYMPATHETIC RESPONSE WITH HIGH FREQUENCY STIMULATION DURING THE FIRST STIMULATION TRIAL, BUT THIS SUBSIDED WHEN STIMULATION WAS SET AT LOW FREQUENCY. A WORSENING OF A PREVIOUS HEADACHE WAS NOTED BY 1 PATIENT. THERE WERE NO OTHER SIDE EFFECTS. IN THIS CASE SERIES, 5 OF 6 PATIENTS WITH PATHOLOGICAL AGGRESSIVENESS HAD A REDUCTION OF THEIR OUTBURSTS OF VIOLENCE AFTER PMH DBS, WITHOUT SIGNIFICANT ADVERSE EFFECTS. PROSPECTIVE CONTROLLED STUDIES WITH A LARGER NUMBER OF PATIENTS ARE NEEDED TO CONFIRM THESE RESULTS. REPORTED EVENT: A FEMALE PATIENT DIED 6 MONTHS AFTER SURGERY AS A CONSEQUENCE OF A STROKE. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450177 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death