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U.S. Department of Health and Human Services

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

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IPG MFG SWITZERLAND REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Premature Discharge of Battery (1057); False Positive Result (1227); Under-Sensing (1661)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2016
Event Type  malfunction  
Manufacturer Narrative
This event occurred outside the u. S. 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, analysis of the device memory indicated undersensing information. Analyst commented, recommended replacement time (rrt) was triggered on (b)(6) 2016. Daily battery trend data shows gradual rise battery impedance. Early rrt alert, without corresponding battery depletion. Several electrocardiogram revealed undersensing. (b)(4).
 
Event Description
It was reported that during use the implantable cardiac monitor (icm) triggered recommended replacement time (rrt) and was reported as premature battery depletion. It was also reported that undersensing was noted. Evaluation of data transmission indicated the icm had an incident where an algorithm falsely triggered rrt. However, the icm will continue to function in spite of the false rrt indication. The icm will be able to transmit non-wirelessly throughout a typical life expectancy for icm devices, and the patient will be able to transmit data manually. The icm remains in use, and no patient complications have been reported as a result of this event.
 
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Brand NameREVEAL LINQ
Type of DeviceDETECTOR 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 Key5560415
MDR Text Key42747762
Report Number9614453-2016-03101
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2015
Device Model NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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