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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SURETEK; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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BOSTON SCIENTIFIC NEUROMODULATION SURETEK; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-4600C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Confusion/ Disorientation (2553); Speech Disorder (4415)
Event Date 08/08/2023
Event Type  Injury  
Event Description
It was reported that the deep brain stimulation (dbs) patient experienced symptoms of nausea, difficulty with speech, and mild confusion during a stage one dbs implant procedure.The patient was sedated with local anesthesia and the procedure was rescheduled.The patient was treated with an intravenous line (iv) medication and their symptoms improved.The patients symptoms continued even after the stimulation was turned off.The physician examined the patients face and did not see any asymmetry nor did they detect any strength imbalances that may indicate a brain bleed.The patients blood pressure remained normal during the entire procedure.The physician decided to stop the procedure prior to any of the leads being implanted.The patient was discharged from the hospital the next day and was back to normal.The cause of the difficulty with speech and mild confusion symptoms are unknown.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient experienced symptoms of nausea, difficulty with speech, and mild confusion.The patient was treated with an intravenous line (iv) medication and their symptoms improved.The patients symptoms continued even after the stimulation was turned off.The physician examined the patients face and did not see any asymmetry nor did they detect any strength imbalances that may indicate a brain bleed.The patients blood pressure remained normal during the entire procedure.The physician decided to stop the procedure prior to any of the leads being implanted.The patient was discharged from the hospital the next day and was back to normal.The cause of the difficulty with speech and mild confusion symptoms are unknown.
 
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Brand Name
SURETEK
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112 5798
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key17653990
MDR Text Key322324169
Report Number3006630150-2023-05191
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/22/2023
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 Health Professional
Device Model NumberDB-4600C
Device Catalogue NumberDB-4600C
Device Lot Number31173550
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/08/2023
Initial Date FDA Received08/30/2023
Supplement Dates Manufacturer Received08/30/2023
Supplement Dates FDA Received09/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2023
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) Other;
Patient Age50 YR
Patient SexMale
Patient RaceWhite
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