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 Unspecified Infection (1930); Inflammation (1932)

Event Date 01/28/2023

Event Type  Injury  

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7081511; product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7080686.

Event Description

It was reported that the patient experienced an infection on their deep brain stimulation (dbs) lead extension area.The physician assessed there was redness and inflammation around the lead extension area and noted the infection was not to be device related.The patient underwent a procedure and had the dbs lead extensions and implantable pulse generator (ipg) removed.Cultures were taken although the results are unavailable.The devices were discarded by the facility and will not return for analysis.

• 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: 16422953
• MDR Text Key: 310042179
• Report Number: 3006630150-2023-00772
• 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: 02/22/2023

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: 01/25/2023
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 503521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2023
• Initial Date FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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: 71 YR
• Patient Sex: Male