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 report with the FDA on 2020-03-30 for REVEAL LINQ LNQ11 manufactured by Medtronic Europe Sarl.

Event Text Entries

[185508292] Product event summary: the device was returned and analyzed. The returned device had a broken crystal. Hybrid analysis confirmed the no-telemetry condition. The cause of the no-telemetry was a defective crystal oscillator which is used to generate the telemetry clock. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185508293] It was reported that the implantable cardiac monitor (icm) patient died as a result of a gunshot wound to the chest. The device explanted and returned for analysis. Analysis of the device was performed and the device tested out of specification. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614453-2020-01105
MDR Report Key9897262
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2019-10-24
Date Mfgr Received2020-03-19
Device Manufacturer Date2018-09-06
Date Added to Maude2020-03-30
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 EUROPE SARL
Manufacturer StreetROUTE DU MOLLIAU 31 CASE POSTALE
Manufacturer CityTOLOCHENAZ VAUD 1131
Manufacturer CountryCH
Manufacturer Postal Code1131
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREVEAL LINQ
Generic NameDETECTOR AND ALARM, ARRHYTHMIA
Product CodeDSI
Date Received2020-03-30
Returned To Mfg2019-11-14
Model NumberLNQ11
Catalog NumberLNQ11
Device Expiration Date2019-08-28
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC EUROPE SARL
Manufacturer AddressROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-30

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