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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 12/19/2015
Event Type  Injury  
Manufacturer Narrative
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Product event summary: the device was returned and analyzed and no anomalies were found. Analysis of the device memory indicated the battery impedance trend was rising. Recommended replacement time (rrt) alert was triggered on (b)(6) 2015. Daily battery trend data shows gradual rise of battery impedance. This was a premature rrt alert, without corresponding battery depletion. (b)(4).
 
Event Description
It was reported that the implantable cardiac monitor (icm) had alerted for recommended replacement time (rrt) without corresponding battery depletion and that the battery had depleted early. The icm was explanted and replaced. No patient complications have been reported as a result of this event.
 
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.
 
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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 Key5559908
MDR Text Key42608601
Report Number9614453-2016-02036
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,consum
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/03/2016
1 Device was Involved in the Event
1 Patient was 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 Date06/28/2015
Device Model NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/07/2016 Patient Sequence Number: 1
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