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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Failure to Interrogate (1332); Battery Problem (2885); Reset Problem (3019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implantable cardiac monitor (icm) exhibited an electrical reset and was unable to be interrogated. It was noted that the device had reached recommended replacement time (rrt). The icm remains in use, however explant is planned. 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)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10313240
MDR Text Key200028609
Report Number9614453-2020-02282
Device Sequence Number1
Product Code DSI
UDI-Device Identifier00643169732216
UDI-Public00643169732216
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2017
Device Model NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2016
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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