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

Model Number LNQ11

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

Non-healthcare professional this device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the implantable cardiac monitor (icm) patient experienced symptoms that could be a potential infection.The patient reported they have been "worked up and worked up and worked up".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: 7747221
• MDR Text Key: 115932271
• Report Number: 9614453-2018-02761
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00643169547940
• UDI-Public: 00643169547940
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: Lay User/Patient
• Device Expiration Date: 04/28/2016
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1249-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR