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

Model Number W1DR

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

It was reported that this device was explanted due to therapy upgrade/downgrade.A new device was placed.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: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 18698205
• MDR Text Key: 335462022
• Report Number: MW5151505
• 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: 01/18/2024

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
• Device Model Number: W1DR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2024
• Patient Sequence Number: 1