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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-1416
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Cognitive Changes (2551); Movement Disorder (4412); Speech Disorder (4415)
Event Date 01/19/2024
Event Type  Injury  
Event Description
It was reported that the deep brain stimulation (dbs) patient experienced a stroke shortly after the dbs implant procedure.The patient was not recovering well and was experiencing issues with speech, cognition, and gait.The patient was transferred to an inpatient rehab facility.The patient later experienced a fall.A computed tomography (ct) scan was performed with no sign of bleeding found on the scan.The patient's gait, cognition and speech were improving but the neurologist did observe some one-sided weakness on the right side and ordered a full magnetic resonance imaging (mri) for further evaluation.The patient was later discharged from the rehab facility and was recovering well.
 
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Brand Name
VERCISE GENUS
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key18846844
MDR Text Key337007759
Report Number3006630150-2024-01242
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729985020
UDI-Public08714729985020
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/06/2024
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? Yes
Device Operator Health Professional
Device Model NumberDB-1416
Device Catalogue NumberDB-1416
Device Lot Number221286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/08/2024
Initial Date FDA Received03/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2023
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 Age82 YR
Patient SexFemale
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