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 Problem Cognitive Changes (2551)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: 7073540.Product family: dbs-linear leads, upn: m365db2202300, model: db-2202-30, serial: (b)(4), batch: 7071266.

Event Description

It was reported that the patient was admitted to the hospital due to moderate cognitive decline.The patient was treated with medication, underwent a revision procedure, and had their device reprogrammed.The patient was then discharged but the outcome is unknown.The physician assessed the event as not related to procedure and device hardware, but causally related to device stimulation.

Event Description

It was reported that the patient was admitted to the hospital due to moderate cognitive decline.The patient was treated with medication, underwent a revision procedure, and had their device reprogrammed.The patient was then discharged but the outcome is unknown.The physician assessed the event as not related to procedure and device hardware, but causally related to device stimulation.Additional information was received that the revision procedure was performed because the patient felt that stimulation with higher current on the left side was leading to the cognitive dysfunction.During the revision procedure, the lead was pulled back by 2.5 contacts.

• 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: 13046239
• MDR Text Key: 282548807
• Report Number: 3006630150-2021-07150
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 01/24/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2022
• Device Model Number: DB-1200
• Device Catalogue Number: DB-1200
• Device Lot Number: 742711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/04/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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): Required Intervention
• Patient Sex: Male