MAUDE Adverse Event Report: MEDTRONIC, INC. IMPLANTABLE PULSE GENERATOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number 1699TC

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported this lead was capped due to product performance issue.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IMPLANTABLE PULSE GENERATOR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 18002976
• MDR Text Key: 326599683
• Report Number: MW5147314
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 10/04/2023

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
• Device Model Number: 1699TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2023
• Patient Sequence Number: 1