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 Suicidal Ideation (4429)

Event Date 11/09/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study a4010 attempted suicide.The patient was admitted to the hospital and treated with medication.The event resolved the same day.The relationship to the serious adverse event was reported as possibly related to stimulation and not related to the procedure or hardware.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202300.Model: db-2202-30.Serial: (b)(6).Batch: 7079542.Product family: dbs-linear leads.Upn: m365db2202300.Model: db-2202-30.Serial:(b)(6).Batch: 7079557.

Event Description

It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study (b)(6) attempted suicide.The patient was admitted to the hospital and treated with medication.The event resolved the same day.The relationship to the serious adverse event was reported as possibly related to stimulation and not related to the procedure or hardware.Additional information was received indicating that the subject had deterioration of mood and cognition and suicidal ideation in the weeks prior on several occasions.

Event Description

It was reported that the deep brain stimulation (dbs) clinical patient enrolled in clinical study (b)(6) attempted suicide.The patient was admitted to the hospital and treated with medication.The event resolved the same day.The relationship to the serious adverse event was reported as possibly related to stimulation and not related to the procedure or hardware.Additional information was received indicating that the subject had deterioration of mood and cognition and suicidal ideation in the weeks prior on several occasions.Additional information was received indicating the initial event date reported of (b)(6) 2023 was incorrect and the correct event date was on (b)(6) 2023.

Manufacturer Narrative

Correction to block 3 date of event based on additional information received on 25 mar 2024.

• 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: 18436288
• MDR Text Key: 331803614
• Report Number: 3006630150-2024-00004
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 560449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 03/25/2024
• Supplement Dates FDA Received: 02/28/2024; 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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): Required Intervention; Hospitalization
• Patient Sex: Female