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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Dysphagia/ Odynophagia (1815)
Event Date 03/02/2021
Event Type  Injury  
Event Description
It was reported that the patient received a deep brain stimulator full implant with a complication of cortical cerebral contusion, generating a plegia on the right hand.The stimulation was activated and in some days the plegia was restored.The patient went to a rehabilitation center to improve the motor outcome for its complication.The patient also underwent a thorax x-ray with normal results and a nasal-gastric probe was inserted to avoid dysphagia.
 
Event Description
It was reported that the patient received a deep brain stimulator full implant with a complication of cortical cerebral contusion, generating a plegia on the right hand.The stimulation was activated and in some days the plegia was restored.The patient went to a rehabilitation center to improve the motor outcome for its complication.The patient also underwent a thorax x-ray with normal results and a nasal-gastric probe was inserted to avoid dysphagia.
 
Manufacturer Narrative
Correction to initial mdr in box e1: country should be italy and not turkey.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: (b)(4).Model: db-2202-45.Serial: (b)(6).Batch: 7075043.Product family: dbs-extension.Upn: (b)(4).Model: nm-3138-55.Serial: (b)(6).Batch: 7077553.Product family: dbs-linear leads.Upn: (b)(4).Model: db-2202-45.Serial: (b)(6).Batch: 7075039.Product family: dbs-extension.Upn: (b)(4).Model: nm-3138-55.Serial: (b)(6).Batch: 7077552.
 
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Brand Name
VERCISE GEVIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key11610647
MDR Text Key243722004
Report Number3006630150-2021-01364
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/07/2021
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
Device Expiration Date08/10/2022
Device Model NumberDB-1200
Device Catalogue NumberDB-1200
Device Lot Number743846
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/10/2021
Initial Date FDA Received04/02/2021
Supplement Dates Manufacturer Received04/12/2021
Supplement Dates FDA Received05/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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