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 Problems Depression (2361); Unspecified Mental, Emotional or Behavioural Problem (4430)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Event date: exact date unknown, event occurred between december 2021 and january 2022.Additional suspect medical device components involved in the event: product family: dbs-linear leads; upn: m365db2202300; model: db-2202-30; serial: (b)(4); batch: 7074539.Product family: dbs-linear leads; upn: m365db2202300; model: db-2202-30; serial: (b)(4); batch: 7074537.

Event Description

It was reported the patient experienced feelings of helplessness due to worsened general condition with depression, desperation, and spontaneous crying.The physician assessed the patient had developed suspected psychic decompensation which was moderate in severity and determined to be possibly related to stimulation and not related to the device or procedure.The patient was admitted to the hospital and treated with medication.The physician also noted the patient had experienced suicidal ideation and a psychotic episode in the past year, and depression in the 4 weeks before enrollment in the clinical study.

Event Description

It was reported the deep brain stimulation (dbs) clinical study patient (a4010 vercise dbs registry) experienced feelings of helplessness due to worsened general condition with depression, desperation, and spontaneous crying.The physician assessed the patient had developed suspected psychic decompensation which was moderate in severity and determined to be possibly related to stimulation and not related to the device or procedure.The patient was admitted to the hospital and treated with medication.The physician also noted the patient had experienced suicidal ideation and a psychotic episode in the past year, and depression in the 4 weeks before enrollment in the clinical study.Additional information received clarified the physician assessed the patient had developed suspected psychiatric decompensation which was moderate in severity.

• 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: 15246370
• MDR Text Key: 298108445
• Report Number: 3006630150-2022-04142
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/05/2022

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: 06/08/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 513738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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
• Patient Sex: Female