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 Abscess (1690); Bacterial Infection (1735); Fever (1858); Unspecified Infection (1930); Inflammation (1932)

Event Date 03/23/2024

Event Type  Injury  

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: (b)(6).Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the deep brain stimulation (dbs) patient went to the emergency room (er) with ongoing fever symptoms such as high fever, puss build-up, and inflammation.The on-call surgeon determined that there was an infection at the implantable pulse generator (ipg) site.The patient underwent an explant procedure where the ipg was explanted and the two lead extensions were cut, leaving the other half connected to the leads.A culture was taken but the results are unknown.It could not be determined if the infection was related to the device.The patient was treated with intravenous (iv) antibiotics and has fully recovered.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial/ batch: (b)(6).Product family: dbs-extension; upn: m365nm3138550; model: nm-3138-55; serial/ batch: (b)(6).

Event Description

It was reported that the deep brain stimulation (dbs) patient went to the emergency room (er) with ongoing fever symptoms such as high fever, puss build-up, and inflammation.The on-call surgeon determined that there was an infection at the implantable pulse generator (ipg) site.The patient underwent an explant procedure where the ipg was explanted and the two lead extensions were cut, leaving the other half connected to the leads.A culture was taken but the results are unknown.It could not be determined if the infection was related to the device.The patient was treated with intravenous (iv) antibiotics and has fully recovered.Additional information was received that the pus was not discovered until the ipg was explanted.The physician could not confirm if the infection was device related.A culture was taken and confirmed meticillin-sensitive staphylococcus aureus (mssa).It was noted that half of the lead extensions were discarded and the other half remain implanted.The patient was doing well postoperatively.

• 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: 19169758
• MDR Text Key: 340899419
• Report Number: 3006630150-2024-02565
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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 Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 592839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2023
• 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: 71 YR
• Patient Sex: Male
• Patient Race: White