MAUDE Adverse Event Report: MEDTRONIC DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the device was explanted due to dissatisfaction with the product.No additional 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: DETECTOR AND ALARM, ARRHYTHMIA
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17528617
• MDR Text Key: 321281304
• Report Number: MW5135547
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: LNQ11
• Patient Sequence Number: 1