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

Model Number DB-1200-S

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

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); No Code Available (3191); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/19/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5120823.Product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 5123230.The device was not returned for analysis and the complaint of infection could not be confirmed.Record review revealed no additional information related to the complaint.The investigation is unable to determine a probable cause for the complaint; therefore, the cause cannot be established.

Event Description

It was reported that an infection at the patients ipg pocket site was discovered during a post-implant follow-up appointment.Cultures were taken and revealed that the patient had a staph infection at the ipg pocket, lead and burr hole site.Patient then had a right picc line placed and underwent infusion therapy and was placed on antibiotics for 4-6 weeks.Patient underwent a full explant of the device, and is doing well post-operatively; and has since had a new device re-implanted.

Manufacturer Narrative

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 an infection at the patients ipg pocket site was discovered during a post-implant follow-up appointment.Cultures were taken and revealed that the patient had a staph infection at the ipg pocket, lead and burr hole site.Patient then had a right picc line placed and underwent infusion therapy and was placed on antibiotics for 4-6 weeks.Patient underwent a full explant of the device, and is doing well post-operatively; and has since had a new device re-implanted.Additional information was received that the patient experienced erythema and edema on the right chest at the location of the ipg pocket site.

• Brand Name: VERCISE GEVIA
• 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: 10140489
• MDR Text Key: 194754058
• Report Number: 3006630150-2020-02421
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729984443
• UDI-Public: 08714729984443
• 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: 08/22/2023

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: 07/17/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 739380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 05/19/2020
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2019
• 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: 77 YR
• Patient Sex: Male