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

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.

• 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 Key: 17653990
• MDR Text Key: 322324169
• Report Number: 3006630150-2023-05191
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• 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

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DB-4600C
• Device Catalogue Number: DB-4600C
• Device Lot Number: 31173550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Race: White