MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problems Migration or Expulsion of Device (1395); Material Protrusion/Extrusion (2979)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implantable cardiac monitor (icm) "pulls out of chest about 1/2 in" when the patient lays a certain way on right side.It was further reported that it "hurts and feels kind of like tattoo/tearing of skin and has to hold hand over chest to make sure that doesn't do that and that sticks out when driving".The icm remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: REVEAL LINQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7766676
• MDR Text Key: 116869826
• Report Number: 9614453-2018-02794
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00643169845749
• UDI-Public: 00643169845749
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2018
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 10/20/2017
• 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
• Patient Age: 35 YR