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

Model Number DB-1200

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

Patient Problems Anxiety (2328); Depression (2361); Suicidal Ideation (4429)

Event Date 01/10/2022

Event Type  Injury  

Event Description

It was reported that a clinical trial patient had attempted suicide.The patient was hospitalized and treated with medication.The patient was discharged and the event has resolved.The investigator has deemed this event to unlikely be related to the stimulation and not related to the procedure or device.

Event Description

It was reported that a clinical trial patient had attempted suicide.The patient was hospitalized and treated with medication.The patient was discharged and the event has resolved.The investigator has deemed this event to unlikely be related to the stimulation and not related to the procedure or device.Additional information was received that the clinical trial patient reported experiencing an increase in anxiety and depression a week prior to their admission to the hospital.The patient attempted suicide by acetaminophen intoxication.While in the hospital, the patient was treated with activated charcoal and was subsequently discharged the following day.

Manufacturer Narrative

Correction to the initial report source.

• Brand Name: VERCISE GEVIA
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14429536
• MDR Text Key: 291926985
• Report Number: 3006630150-2022-02291
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2023
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 746726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• 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