REVEAL LINQ LNQ11

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for REVEAL LINQ LNQ11 manufactured by Medtronic Singapore Operations.

Event Text Entries

[185574597] 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 false asystole due to undersensing. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185574598] It was reported that on the day following the implant procedure, the implantable cardiac monitor (icm) detected a false pause episode suggested to be due to device moving within the pocket. The device remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[186640331] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3008973940-2020-00752
MDR Report Key9888024
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-31
Date of Event2020-03-18
Date Mfgr Received2020-03-27
Device Manufacturer Date2020-02-05
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactPAULA BIXBY
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635055378
Manufacturer G1MEDTRONIC SINGAPORE OPERATIONS
Manufacturer Street49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE
Manufacturer CitySINGAPORE 486056
Manufacturer CountrySG
Manufacturer Postal Code486056
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREVEAL LINQ
Generic NameDETECTOR AND ALARM, ARRHYTHMIA
Product CodeDSI
Date Received2020-03-27
Model NumberLNQ11
Catalog NumberLNQ11
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SINGAPORE OPERATIONS
Manufacturer Address49 CHANGI SOUTH AVENUE 2 NASACO TECH CENTRE SINGAPORE 486056 SG 486056


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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