MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Patient Problems Failure of Implant (1924); Shaking/Tremors (2515)

Event Type  malfunction  

Event Description

On (b)(6) 2024, the deep brain stimulation (dbs) patient underwent an explant procedure where the medtronic leads removed due to inadequate stimulation resulting in lack of tremor control.The explant occurred at (b)(6) with dr.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 19078884
• MDR Text Key: 339922014
• Report Number: MW5153680
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/19/2024

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: 04/09/2024
• Patient Sequence Number: 1