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

Model Number LNQ11

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661)

Patient Problem Loss of consciousness (2418)

Event Date 04/29/2018

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 patient "passed out twice" and the implantable cardiac monitor (icm) experienced false pause detection due to oversensing of baseline noise.The device remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing due to electromagnetic interference/noise.Analysis of the device memory indicated false asystole due to undersensing.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: 7561982
• MDR Text Key: 109824278
• Report Number: 9614453-2018-02116
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2018
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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: 31 YR