BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 3825066 · Received May 21, 2014

    Report

    Report Number
    3007566237-2014-01398
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 24, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ACTUAL DATE OF DEATH WAS 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. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ROCHA, S., MONTEIRO, A., LINHARES, P., CHAMADOIRA, C., BASTO, M. A., REIS, C., SOUSA, C., LIMA, J., ROSAS, M.J., MASSANO, J., VAZ, R. LONG-TERM MORTALITY ANALYSIS IN PARKINSON'S DISEASE TREATED WITH DEEP BRAIN STIMULATION. PARKINSON'S DISEASE. 2014;2014. HTTP://D X.DOI.ORG/10.1155/2014/717041 SUMMARY: FEW DATA HAVE BEEN PUBLISHED REGARDING LONG-TERM MORTALITY IN PATIENTS WITH PARKINSON¿S DISEASE TREATED WITH DBS. THIS STUDY ANALYZED LONG-TERM MORTALITY RATES, CAUSES, AND CORRELATES IN PD PATIENTS TREATED WITH DBS. ONE HUNDRED EIGHTY FOUR (184) CONSECUTIVE PATIENTS WERE INCLUDED; MEAN FOLLOW-UP WAS 50 MONTHS. FIFTEEN DEATHS OCCURRED (TOTAL 8.15%, ANNUAL MORTALITY RATE 1.94%). MEAN AGE AT DISEASE ONSET AND AT SURGERY WAS 48 ± 2.4 AND 63 ± 1.6 YEARS, RESPECTIVELY. MEAN DISEASE DURATION UNTIL DEATH WAS 21 ± 7.8 YEARS. MOST DEATHS RELATED TO STROKE, MYOCARDIAL INFARCTION, OTHER VASCULAR/HEART DISORDERS, OR SEVERE INFECTION; ONE SUICIDE WAS RECORDED. DECEASED PD PATIENTS WERE MOSTLY MALE AND HAD LOWERMOTOR BENEFIT AFTER DBS, BUT UNIVARIATE ANALYSIS FAILED TO SHOW SIGNIFICANT DIFFERENCES REGARDING GENDER AND MOTOR BENEFIT. SURVIVAL WAS 99% AND 94% AT 3 AND 5 YEARS. LONG TERM SURVIVAL IS TO BE EXPECTED IN PD PATIENTS TREATED WITH DBS, POSSIBLY HIGHER THAN PREVIOUSLY EXPECTED. DEATH USUALLY SUPERVENES DUE TO VASCULAR EVENTS OR INFECTION. REPORTED EVENTS: ONE MALE PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE DIED OF AN ISCHEMIC STROKE 72 MONTHS AFTER IMPLANT. THE SOURCE LITERATURE DID NOT INCLUDE SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO OBSERVED DEVICE MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302586 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 742859 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death