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 Bacterial Infection (1735); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 03/01/2023

Event Type  Injury  

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced an infection and had a wash out procedure to clear the infection out.Over the past several months, it seems that the infection has not completely cleared out.

Event Description

It was reported that the deep brain stimulation (dbs) patient experienced an infection and had a wash out procedure to clear the infection out.Over the past several months, it seems that the infection has not completely cleared out.Additional information was received that the infection was located at the implantable pulse generator (ipg), lead extension and leads.In additional, there was swelling at the lead connector site.A culture was performed and staphylococcus epidermidis and c.Acnes were confirmed.The patient was treated with intravenous (iv) rifampin and bactrim.The devices were explanted and then re-implanted.The patient was doing well postoperatively.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads upn: (b)(4) model: db-2202-45 serial: (b)(6) batch: 7085478 product family: dbs-linear leads upn: (b)(4) model: db-2202-45 serial: (b)(6) batch: 7085549 product family: dbs-lead fixation upn: (b)(4) model: db-4600c serial: n/a batch: 7085549 product family: dbs-extension upn: (b)(4) model: nm-3138-55 serial: (b)(6) batch: 7091912 product family: dbs-extension upn: (b)(4) model: nm-3138-55 serial: (b)(6) batch: 7091968.

• 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: 18308256
• MDR Text Key: 330222744
• Report Number: 3006630150-2023-07775
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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 Expiration Date: 07/20/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 517476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 04/01/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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 Age: 57 YR
• Patient Sex: Male