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

Model Number LNQ11

Device Problems False Positive Result (1227); Under-Sensing (1661)

Patient Problems Syncope (1610); No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the recommended replacement time (rrt) alert triggered prematurely on the patient's implantable cardiac monitor (icm).The icm remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

This device was reported as included in the field action noted and returned product investigation found the device performed as described in the field action.Product event summary: the device was returned and analyzed.Analysis of the device memory indicated the battery impedance trend was rising.The recommended replacement time (rrt) alert was triggered on (b)(4) 2016.Daily battery trend data shows a gradual rise of battery impedance.The rrt alert was premature, without corresponding battery depletion.

Manufacturer Narrative

The device was returned and analyzed.Analysis of the device memory indicated the battery impedance trend was rising.The recommended replacement time (rrt) alert was triggered on (b)(6) 2016.Daily battery trend data shows a gradual rise of battery impedance.The rrt alert was premature, without corresponding battery depletion.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was later reported that the icm was suspected to have demonstrated undersensing.The patient was reported to have experienced a syncopal episode.

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: 5577189
• MDR Text Key: 42683843
• Report Number: 9614453-2016-03266
• Device Sequence Number: 1
• Product Code: DSI
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/2015
• 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: 03/08/2016
• Initial Date FDA Received: 04/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 09/28/2016
• Supplement Dates FDA Received: 06/09/2016; 12/09/2016; 12/15/2016; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• 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): Life Threatening
• Patient Age: 00085 YR
• Patient Weight: 83