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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 Problem Cerebrospinal Fluid Leakage (1772)
Event Date 02/16/2018
Event Type  Injury  
Event Description
A report was received that the patient complained of clear fluid oozing from the right dbs wound, which was later confirmed to be a cerebral spinal fluid (csf) leak.The patient was treated with antibiotics and underwent a re-suturing of the wound.The patient was discharged and the issue is considered recovered.The reported event is related to the study procedure and not related to the device or stimulation.
 
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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 Key7392577
MDR Text Key104189951
Report Number3006630150-2018-01241
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
Report Date 04/03/2018
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 03/08/2018
Initial Date FDA Received04/03/2018
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) Required Intervention;
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