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

Model Number DB-1232

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

Patient Problems Bacterial Infection (1735); Inflammation (1932); Fluid Discharge (2686)

Event Date 08/09/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7100351.Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7100571.Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7100788.Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial: (b)(4); batch: 7101111.

Event Description

It was reported that the patient experienced redness and discharge at the implantable pulse generator (ipg) pocket site.Therefore, the patient underwent an explant procedure of the deep brain stimulation (dbs) system.The physician assessed that the infection was not related to the device.A culture was taken and the results confirmed the presence of infection.The patient has since been discharged from the hospital and was placed on antibiotics.The explanted devices will not be returned as they were discarded by the medical 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15374919
• MDR Text Key: 299449082
• Report Number: 3006630150-2022-04602
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: 08714729985051
• 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: 09/07/2022

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: 07/08/2023
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 517269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: 19 YR
• Patient Sex: Male