MAUDE Adverse Event Report: BRAIN STIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

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

Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120)

Event Date 10/10/2022

Event Type  Injury  

Event Description

The patient's wife reported that the patient was hospitalized (b)(6) 2022 due to infection around leads of his deep brain stimulator and also due to complications from a urinary tract infection.

• Brand Name: BRAIN STIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• MDR Report Key: 16573921
• MDR Text Key: 311704198
• Report Number: MW5115844
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/15/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2023
• Patient Sequence Number: 1
• Treatment: DROXIDOPA
• Patient Age: 74 YR
• Patient Sex: Male