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 Cardiac Arrest (1762); Unspecified Infection (1930); Staphylococcus Aureus (2058); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), lot: 7072019.Product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), lot: 5177915.Product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), lot: 7072720.Product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), lot: 7072801.

Event Description

It was reported that the patient had drainage and poor would healing at the right side cranial incision site.Physician assessed that the patient had an infection.Cultures taken tested positive for staphylococcus aureus and curtibacterium acnes.Patient then underwent an explant procedure to remove the entire dbs system, and was placed on antibiotics via picc line.Post-operatively the patient suffered acute kidney injury and a heart block that resulted in the placement of a pacemaker likely due to the antibiotics.Patient is now doing well.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10548170
• MDR Text Key: 207383248
• Report Number: 3006630150-2020-04280
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

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: 12/16/2021
• Device Model Number: DB-1200-S
• Device Catalogue Number: DB-1200-S
• Device Lot Number: 741319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• 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: 66 YR