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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; DEEP BRAIN STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION; DEEP BRAIN STIMULATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2017
Event Type  Injury  
Manufacturer Narrative
1968 (exact date of birth unknown).
 
Event Description
A report was received that the patient was admitted due to increasing gait disorder with episodes of freezing that were moderate in severity.The patients device and medications were adjusted and an improvement in the freezing symptoms were observed, with more fluid gait was observed.The patient and the event have recovered and resolved and the patient was discharged.The event was assesses as unlikely related to the study stimulation and not related to the procedure or device.
 
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Brand Name
NI
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 Key7515170
MDR Text Key108288367
Report Number3006630150-2018-01700
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeGM
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 05/15/2018
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 04/18/2018
Initial Date FDA Received05/15/2018
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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