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); Purulent Discharge (1812); Post Operative Wound Infection (2446)

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown, event occurred between (b)(6) 2023.Additional suspect medical device components involved in the event: product family: dbs-extension upn: m365db312855b0, model: db-3128-55b, serial: (b)(6), batch: 5000962.Product family: dbs-linear leads upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: 7080363.Product family: dbs-linear leads upn: m365db2202300, model: db-2202-30, serial: (b)(6), batch: 7080420.Product family: dbs-lead fixation upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 31084869.Product family: dbs-lead fixation upn: m365db4600c0, model: db-4600c, serial: n/a, batch: 31359711.

Event Description

It was reported that the patient had purulent discharge excreting from the deep brain stimulation (dbs) neck and chest incision sites.Cultures were taken confirmed the presence of infection; however, the specific results were not provided.The patient was prescribed intravenous (iv) antibiotics and scheduled to have the dbs system removed.The first of two procedures removed the implantable pulse generator (ipg) and lead extension; and a week later, the remaining leads and burr hole covers were removed.Physical analysis could not be performed in our laboratory, as the devices 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: 17936376
• MDR Text Key: 325675312
• Report Number: 3006630150-2023-06250
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2023

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 576123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White