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 Emotional Changes (1831); Dyskinesia (2363)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported that the patient (clinical study number (b)(4) developed moderate impulse control and worsening of dyskinesia following deep brain stimulation device implantation.The patient was admitted to the hospital for routine standard of care where medication was administered , the device was reprogrammed, and a computed tomography (ct) scan was done which showed no abnormalities.The reported event has resolved and the patient was discharged same day.The physician assessed the event as having had a probable relationship to stimulation, and not related to the procedure or device hardware.

Manufacturer Narrative

Date of event: exact date unknown, event occurred in (b)(6) 2021 additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: unk, model: unk, serial: unk, batch: unk.Product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: 7081617.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13321226
• MDR Text Key: 284616285
• Report Number: 3006630150-2022-00107
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 01/21/2022

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: 08/12/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 518396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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): Other