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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 Edema (1820); Loss of consciousness (2418); No Code Available (3191)
Event Date 11/25/2020
Event Type  Injury  
Event Description
It was reported that the patient has not regained consciousness after undergoing a ipg implant procedure.The patient remains in a high dependency ward.The physician has not checked the post-op ct scan for lead placement, but the surgeon reported no blood was on the scan.
 
Manufacturer Narrative
Block h6 patient code 3191: no code available was used as there is no equivalent fda code for additional intervention.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: (b)(4).Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: (b)(4).
 
Event Description
It was reported that the patient has not regained consciousness after undergoing a ipg implant procedure.The patient remains in a high dependency ward.The physician has not checked the post-op ct scan for lead placement, but the surgeon reported no blood was on the scan.Additional information was received that the neurologist confirmed that the patient has edema along the lead trajectory, which has caused her reported symptoms.The neurologist assessed the event as being not device related, but was caused by the implant procedure.The neurologist believes that the patients anatomy may have made her more susceptible.The patient is slowly recovering and her original motor symptoms have since resolved, even with the ipg switched off due to surgery.The patient is currently inpatient at a rehabilitation ward and medical treatment will be provided as standard of care.The neurologist is planning on turning stimulation on when the patient is fully recovered.
 
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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 Key10995002
MDR Text Key221223435
Report Number3006630150-2020-06167
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 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/15/2022
Device Model NumberDB-1200
Device Catalogue NumberDB-1200
Device Lot Number744257
Was Device Available for Evaluation? No
Date Manufacturer Received12/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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