MAUDE Adverse Event Report: MEDTRONIC REVEAL LINQ; LOOP RECORDER

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Chest Pain (1776)

Event Date 06/29/2015

Event Type  Injury  

Event Description

Pt had a loop recorder implanted on (b)(6) 2015 for recurrent syncope.On (b)(6) 2015 the pt presented to the ed after experiencing sudden onset of left-sided chest pain while lying down.Pain worsened on movement and deep inspiration.The pain radiated to the left arm and shoulder.The pt was unable to activate the recorder at the usual site at the left parasternal area.In ct scan noted that the loop recorder was malpositioned and found to have migrated down into the left epicardial fat pad.On (b)(6) 2015 was taken to surgery to explant of the loop recorder.

• Brand Name: REVEAL LINQ
• Type of Device: LOOP RECORDER
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4898932
• MDR Text Key: 6831766
• Report Number: MW5043690
• Device Sequence Number: 1
• Product Code: MXC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2015

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 Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR