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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE; DEEP BRAIN STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE; DEEP BRAIN STIMULATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Neurological Deficit/Dysfunction (1982)
Event Date 02/02/2018
Event Type  Injury  
Event Description
A report was received that the dbs study patient developed moderate impulsivity.The patient was admitted to the facility and on admission, the patient was agitated and felt overwrought with sudden jolting of the limbs and uncontrolled movement, stereotypical compulsions and inner restlessness.The patient always feels this one hour after taking his medications.The patient was administered medication and the stimulation parameters were reduced.The event has resolved.The event of impulsivity was assessed as possibly related to the device stimulation and not related to the procedure or the device hardware.
 
Manufacturer Narrative
Additional information was received that no further information can be obtained regarding the devices.
 
Event Description
A report was received that the dbs study patient developed moderate impulsivity.The patient was admitted to the facility and on admission, the patient was agitated and felt overwrought with sudden jolting of the limbs and uncontrolled movement, stereotypical compulsions and inner restlessness.The patient always feels this one hour after taking his medications.The patient was administered medication and the stimulation parameters were reduced.The event has resolved.The event of impulsivity was assessed as possibly related to the device stimulation and not related to the procedure or the device hardware.
 
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Brand Name
VERCISE
Type of Device
DEEP BRAIN STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key7314841
MDR Text Key101559610
Report Number3006630150-2018-00918
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2018
Initial Date FDA Received03/05/2018
Supplement Dates Manufacturer Received02/26/2018
Supplement Dates FDA Received03/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age59 YR
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