MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION DEEP BRAIN STIMULATION SYSTEM; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Device Problem Energy Output Problem (1431)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

We were informed on (b)(6) 2019 about an event regarding a patient with medtronic deep brain stimulation system undergoing a procedure to remove the system due to inadequate stimulation.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Refer to add'l documents in i2k.

• Brand Name: DEEP BRAIN STIMULATION SYSTEM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 17278794
• MDR Text Key: 318613397
• Report Number: MW5119165
• 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: Other
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Patient Sequence Number: 1