MAUDE Adverse Event Report: MEDTRONIC DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Event Description

This device was implanted on (b)(6) 2014.And was explanted on (b)(6) 2016.A procedure form received, stating that the implant site looked mildly inflamed with tenderness to palpation.It was also recommended, that the site should be given concern for infection.And a culture swab were sent.The physician was dr.(b)(6) at (b)(6) at the (b)(6).No other information is available.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: 17524256
• MDR Text Key: 321092303
• Report Number: MW5131203
• 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: 01/13/2017

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?: No
• Device Model Number: LNQ11
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1