MAUDE Adverse Event Report: 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 Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-ipg-r-mri, upn: m365db12160, model: db-1216, serial: (b)(6), batch: 592881.

Event Description

It was reported that the deep brain stimulation (dbs) patient was admitted to the hospital for a possible infection.The patient had symptoms of redness, hives, itchiness, and inflammation around the chest incisions.Irrigation and debridement were performed.No infection was found.The physician stated that he thinks the issue resulted from an allergy to an antibacterial cream that was prescribed to the patient.The location of the allergy and hives were on the patients chest, back, arms, and legs.The patient was treated with another round of antibiotics and a steroid.The patients hives and itchiness have subsided slightly.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• MDR Report Key: 18718000
• MDR Text Key: 335527268
• Report Number: 3006630150-2024-00730
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Type of Report: Initial
• Report Date: 02/15/2024

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: 592081
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• 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: 67 YR
• Patient Sex: Male