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

Model Number DB-1416

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 01/09/2024

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient underwent an explant procedure to remove the implantable pulse generator (ipg) and two extensions due to infection.It was noted that the patient began experiencing purulent drainage at the pocket site the day of the implant procedure.The physician would not release information regarding culture results, or whether or not antibiotics were prescribed.The devices were not analyzed by our laboratory, as they were retained by the facility.

Manufacturer Narrative

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

• 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: 19052988
• MDR Text Key: 339523692
• Report Number: 3006630150-2024-02098
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985020
• UDI-Public: 08714729985020
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

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 Model Number: DB-1416
• Device Catalogue Number: DB-1416
• Device Lot Number: 222377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2023
• 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: 71 YR
• Patient Sex: Male