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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Erythema (1840); Unspecified Infection (1930); Increased Sensitivity (2065); Fluid Discharge (2686)
Event Date 02/12/2019
Event Type  Injury  
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) patient experienced erythema and infection at the device site and "a pin size opening appeared with clear drainage". It was further reported that the area was tender to touch and a small scab developed at the proximal end of the device. It was noted that the patient had lost approximately twenty ponds pounds. The icm was explanted and patient was placed on oral antibiotics. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Product event summary: the device was returned and analyzed. Returned product analysis was performed and no anomalies were found. 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)
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
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8393848
MDR Text Key137924587
Report Number9614453-2019-00683
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132649
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 04/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/06/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/28/2018
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/25/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/06/2017
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: 03/06/2019 Patient Sequence Number: 1
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