MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number ILR-INSERTION-TOOL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tachycardia (2095)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).

Event Description

It was reported that during insertion of the implantable cardiac monitor (icm), the patient went into supra ventricular tachycardia (svt).Valsalva maneuvers were used and carotid massage was attempted but failed.The svt broke without the use of medication.The device is still in use.The patient is enrolled in the (b)(6) study.No further patient complications have been reported as a result of this event.

• Brand Name: REVEAL LINQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5425814
• MDR Text Key: 37842452
• Report Number: 2182208-2016-00558
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ILR-INSERTION-TOOL
• Device Catalogue Number: ILR-INSERTION-TOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2015
• Initial Date FDA Received: 02/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LNQ11 IMPLANTABLE CARDIAC MONITOR (ICM)
• Patient Outcome(s): Required Intervention
• Patient Age: 00024 YR