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

Model Number DB-1408

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

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Swelling/ Edema (4577)

Event Date 03/03/2023

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-linear leads.Upn: m365db2202450, model: db-2202-45, serial: (b)(4).Batch: 7083733.Product family: dbs-extension.Upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7093684.

Event Description

It was reported that the patient experienced an infection at the incision site on top of the lead extension and lead connection site.The area was red, swollen, and there was puss.The patient underwent an explant procedure in which the entire deep brain stimulation (dbs) system, implantable pulse generator (ipg), leads and lead extensions were explanted, and he was prescribed antibiotics.Cultures were taken and confirmed there was staphylococcus aureus infection.The physician indicated that the infection was not device related.The patient is not doing well postoperatively.The devices will not be returned for analysis as they were retained by the facility.

• 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: 16632753
• MDR Text Key: 312192090
• Report Number: 3006630150-2023-01618
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729989752
• UDI-Public: 08714729989752
• 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: 03/28/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/24/2023
• Device Model Number: DB-1408
• Device Catalogue Number: DB-1408
• Device Lot Number: 204617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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: 67 YR
• Patient Sex: Male