BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7050702 · Received November 21, 2017

    Report

    Report Number
    3007566237-2017-04914
    Event Type
    Death
    Date Received
    November 21, 2017
    Report Date
    February 18, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION OF THE PUBLISHED ARTICLE WAS RECEIVED: WEAVER FM, STROUPE KT, SMITH B, GONZALEZ B, HUO Z, CAO L, IPPOLITO D, FOLLETT KA. SURVIVAL IN PATIENTS WITH PARKINSON'S DISEASE AFTER DEEP BRAIN STIMULATION OR MEDICAL MANAGEMENT. MOVEMENT DISORDERS PUBLISHED ONLINE DOI: 10.1002/MDS.27235. 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

    PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR THE REPORTED EVENTS WERE FROM THE FOLLOWING LITERATURE ARTICLE AND ITS ACCOMPANYING SUPPLEMENTAL MATERIAL: WEAVER FM, STROUPE KT, SMITH B, GONZALEZ B, HUO Z, CAO L, IPPOLITO D, FOLLETT KA. SURVIVAL IN PATIENTS IN PARKINSON¿S DISEASE AFTER DEEP BRAIN STIMULATION OR MEDICAL MANAGEMENT. PRIOR TO PUBLICATION. ABSTRACT: DEEP BRAIN STIMULATION HAS BEEN SHOWN TO HAVE A SIGNIFICANT AND LONG TERM BENEFICIAL EFFECT ON MOTOR FUNCTION. HOWEVER, WHETHER IT AFFECTS SURVIVAL IS NOT CLEAR. IN THIS STUDY, WE COMPARED SURVIVAL RATES FOR PARKINSON¿S DISEASE (PD) PATIENTS WHO UNDERWENT DEEP BRAIN STIMULATION (DBS) TO THOSE WHO WERE MEDICALLY MANAGED. RETROSPECTIVE ANALYSIS OF VA AND MEDICARE ADMINISTRATIVE DATA OF VETERANS WITH PD WHO RECEIVED DBS WHO WERE PROPENSITY SCORE MATCHED TO A COHORT OF VETERANS WITH PD WHO DID NOT RECEIVE DBS BETWEEN 2007 AND 2013. VETERANS WITH PD WHO RECEIVED DBS HAD A LONGER SURVIVAL MEASURED IN DAYS THAN A MATCHED GROUP OF VETERANS WHO DID NOT UNDERGO DBS. MEAN AGE AT DEATH WAS SIMILAR FOR BOTH GROUPS, RESPECTIVELY, AND THE MOST COMMON CAUSE OF DEATH WAS ¿PARKINSON¿S DISEASE.¿ DBS HAD A SURVIVAL BENEFIT COMPARED TO A MATCHED GROUP OF PATIENTS WHO DID NOT UNDERGO DBS. WHETHER THIS REPRESENTS A DISEASE MODIFYING EFFECT OR A MODERATING INFLUENCE ON PARKINSON¿S DISEASE CO-MORBIDITIES THAT MIGHT SHORTEN LIFE IS NOT YET KNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. -

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE RECEIVED VIA LITERATURE ARTICLE (SEE H10 FOR CITATION): REPORTED EVENTS: 1. 1 PATIENT WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSON¿S DISEASE (PD) DIED AS A COMPLICATION OF DBS SURGERY. 2. 2 PATIENTS WITH DBS FOR PD DIED DUE TO SUICIDE. 3. 2 PATIENTS WITH DBS FOR PD DIED DUE TO ¿STROKE/INTRACEREBRAL HEMORRHAGE/INTRACRANIAL HEMORRHAGE/CVD UNSPECIFIED.¿ 4. 3 PATIENTS WITH DBS FOR PD DIED DUE TO DROWNING. 5. 2 PATIENTS WITH DBS FOR PD DIED DUE TO DEMENTIA. 6. 3 PATIENTS WITH DBS FOR PD DIED DUE TO SEPSIS. THERE WAS NO SPECIFIC PRODUCT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR ADDED THAT THE CAUSE OF DEATH WAS IDENTIFIED AS ¿SURGERY WITH IMPLANT WITH ABNORMAL REACTION OF PATIENT OR LATER COMPLICATION WITHOUT MISADVENTURE AT THE TIME OF PROCEDURE.¿ BASED ON THE DATA AVAILABLE TO THE AUTHORS IT WAS NOT CLEAR WHETHER A DEVICE RELATED ISSUE WAS INVOLVED. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD COMMITTED SUICIDE WITH A FIREARM. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD COMMITTED SUICIDE WITH EXPLOSIVE MATERIAL. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM AN (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO STROKE. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM AN (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO STROKE. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO DROWNING. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO DROWNING IN A SWIMMING POOL. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO DROWNING IN A BATHTUB. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO DEMENTIA. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO DEMENTIA. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM A (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO SEPSIS. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM AN (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO SEPSIS. ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR FROM AN (B)(6) YEAR-OLD MAN WITH DBS FOR PD DIED DUE TO SEPSIS. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING PATIENT AGE AND CLARIFICATIONS ON CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827373 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death