MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1216

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ischemia Stroke (4418)

Event Date 07/04/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) clinical study patient, vercise dbs registry a4010, experienced a transient ischemic attack which was mild in severity.The patient was hospitalized and discharged two days later.The event was assessed as unlikely related to the device.

Event Description

It was reported that the deep brain stimulation (dbs) clinical study patient, vercise dbs registry (b)(6), experienced a transient ischemic attack which was mild in severity.The patient was hospitalized and discharged two days later.The event was assessed as unlikely related to the device.Additional information was received that the event was not related to the device.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17543396
• MDR Text Key: 321098904
• Report Number: 3006630150-2023-04756
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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: Lay User/Patient
• Device Expiration Date: 06/09/2022
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 500556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/21/2023
• Supplement Dates FDA Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male