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

Model Number DB-1200-S

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

Patient Problems Headache (1880); Unspecified Infection (1930); Swelling (2091); No Code Available (3191); Swelling/ Edema (4577)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: db-2202-45, serial/ lot: (b)(4), description: dbs directional lead sterile kit 45cm.

Event Description

It was reported that the patient experienced facial swelling and headaches.The physician determined that the patient had an infection and performed a full system explant.The patient was also treated with antibiotics.The devices were discarded by the facility.

Manufacturer Narrative

A review of the manufacturing documentation for the leads and ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.There is no evidence that the devices were used in a manner inconsistent with the labelled indications.No further review is required.Additional suspect medical device components involved in the event: model: db-2202-45 (b)(6).Description: dbs directional lead sterile kit 45cm h3 other text : devices were discarded by facility.

Event Description

It was reported that the patient experienced facial swelling and headaches.The physician determined that the patient had an infection and performed a full system explant.The patient was also treated with antibiotics.The devices were discarded by the facility.

Manufacturer Narrative

Correction to field bsc aware date.The correct aware date is 11oct2021 and not 17mar2020 as initially reported.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced an infection.The patient underwent a revision procedure where the lead extensions were explanted.The explanted devices were disposed of by the hospital.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7073068.Product family: dbs-extension.Upn: m365nm3138550.Model: nm-3138-55.Serial: (b)(6).Batch: 7073170.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced an infection.The patient underwent a revision procedure where the lead extensions were explanted.The explanted devices were disposed of by the hospital.

• Brand Name: VERCISE GEVIA
• 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: 10010741
• MDR Text Key: 189567714
• Report Number: 3006630150-2020-01923
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2023

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: 02/25/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 737738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/29/2020
• Supplement Dates Manufacturer Received: 05/07/2020; 03/17/2020; 10/11/2021
• Supplement Dates FDA Received: 06/03/2020; 06/30/2023; 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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 Age: 66 YR
• Patient Sex: Male