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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 01/23/2016
Event Type  malfunction  
Manufacturer Narrative
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
 
Event Description
It was reported that the implantable cardiac monitor (icm) had reached the recommended replacement time (rrt) and early battery depletion was presumed although battery voltage still appeared acceptable. The icm remains in use. 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.
 
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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 Key5559900
MDR Text Key42609350
Report Number9614453-2016-02035
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2016
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 Date07/14/2015
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 Received02/02/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/14/2014
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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