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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)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2016
Event Type  Malfunction  
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 the battery impedance trend was rising. Recommended replacement time (rrt) was triggered on (b)(6) 2016 due to impedance. Daily battery trend data shows gradual rise of battery impedance. Early rrt alert, without corresponding battery depletion. 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.

 
Event Description

It was reported that the implantable cardiac monitor (icm) triggered recommended replacement time (rrt) earlier than necessary and it was reported as unexpected longevity. The device remains in use. 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 Key5859328
MDR Text Key51824342
Report Number9614453-2016-04911
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Recall
Type of Report Initial
Report Date 05/16/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/28/2015
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 Received05/16/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/11/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1249-2016

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