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

Model Number	DB-1408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Discomfort (2330); Fluid Discharge (2686)
Date of Event	09/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient developed an infection at the ipg, implantable pulse generator, site and intermediate incision site.The site was observed to be tender and puffy with possible fluid accumulation due to the infection.The patient underwent an explant of their entire system and was placed on antibiotics for four to six weeks.The physician stated that the infection is not device related but the cause is unknown.The patient is doing well.
Additional Manufacturer Narrative
Date of event: approximated based on the date of the procedure.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(4), batch: 7081694.Product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7087898.

• Brand Name: VERCISE GENUS
• Common Device Name: 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: 13539252
• Report Number: 3006630150-2022-00520
• Device Sequence Number: 4359956
• Product Code: NHL
• UDI-Device Identifier: 08714729989752
• UDI-Public: 08714729989752
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/12/2023
• Device Model Number: DB-1408
• Device Catalogue Number: DB-1408
• Device Lot Number: 201402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male