MAUDE Adverse Event Report: IPG MFG SWITZERLAND REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problems Premature Discharge of Battery (1057); False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.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 the battery impedance trend was rising.Analyst commented, recommended replacement time (rrt) alert was triggered on (b)(6) 2016.Daily battery trend data shows gradual rise/varying battery impedance.Premature rrt alert, without corresponding battery depletion.(b)(4).

Event Description

It was reported that during use the implantable cardiac monitor (icm) encountered an incident where an algorithm falsely triggered recommended replacement time (rrt).The icm remains in use as the devices will continue to function in spite of the false rrt indication.Upon eos trigger the icm will automatically switch to non-wireless telemetry only.The patient will be able to transmit manually (or non-wirelessly with the patient wand).No 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): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5559917
• MDR Text Key: 42765696
• Report Number: 9614453-2016-02030
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

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: Lay User/Patient
• Device Expiration Date: 07/14/2015
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: 02/15/2016
• Supplement Dates FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2014
• 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