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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE DBS; DEEP BRAIN STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE DBS; DEEP BRAIN STIMULATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Weakness (2145)
Event Date 10/11/2017
Event Type  Injury  
Event Description
A report was received that the patient developed moderate left sided weakness after the implant procedure.The patient was later admitted following a collapse, moderate in severity, on (b)(6) 2017 and was discharged on (b)(6) 2017.The events were assessed as possibly related to the procedure and hardware.The left sided weakness was not related to the stimulation and the collapse was assessed as unlikely related to the stimulation.
 
Manufacturer Narrative
Additional information was received that the patient was admitted following a syncopal episode which was moderate in severity with no loss of consciousness, chest pain, or headache.Since the implant procedure the patient experienced episodes of syncope and weakness in the arms and legs.No action has been reported.The event of syncopal episode has resolved.No further information could be provided.
 
Event Description
A report was received that the patient developed moderate left sided weakness after the implant procedure.The patient was later admitted following a collapse, moderate in severity, on (b)(6) 2017 and was discharged on (b)(6) 2017.The events were assessed as possibly related to the procedure and hardware.The left sided weakness was not related to the stimulation and the collapse was assessed as unlikely related to the stimulation.
 
Manufacturer Narrative
Additional information was received that the event of left sided weakness was assessed as probably related to the procedure and not related to the stimulation or hardware.The event of syncopal episode was assessed as possibly related to the procedure, unlikely related to the stimulation and not related to the device.
 
Event Description
A report was received that the patient developed moderate left sided weakness after the implant procedure.The patient was later admitted following a collapse, moderate in severity, on (b)(6) 2017 and was discharged on (b)(6) 2017.The events were assessed as possibly related to the procedure and hardware.The left sided weakness was not related to the stimulation and the collapse was assessed as unlikely related to the stimulation.
 
Manufacturer Narrative
Additional information was received that the event of left sided weakness was assessed as left hemiparesis and was moderate in severity.No action was taken and the event resolved.The event was assessed as probably related to the procedure and not related to the stimulation or hardware.
 
Event Description
A report was received that the patient developed moderate left sided weakness after the implant procedure.The patient was later admitted following a collapse, moderate in severity, on (b)(6) 2017 and was discharged on (b)(6) 2017.The events were assessed as possibly related to the procedure and hardware.The left sided weakness was not related to the stimulation and the collapse was assessed as unlikely related to the stimulation.
 
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Brand Name
VERCISE DBS
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 Key7370626
MDR Text Key103462274
Report Number3006630150-2018-01153
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
150031
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,Followup,Followup
Report Date 08/03/2018
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 03/01/2018
Initial Date FDA Received03/26/2018
Supplement Dates Manufacturer Received04/11/2018
05/31/2018
07/23/2018
Supplement Dates FDA Received05/01/2018
06/13/2018
08/03/2018
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;
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