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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 Inappropriate or Unexpected Reset (2959); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2021
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) was not functioning within normal tolerances. The icm was explanted. 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
SZ 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
SZ 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key12056583
MDR Text Key258045019
Report Number9614453-2021-02590
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 HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 08/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/24/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/18/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2182208-052821-004-C

Patient TREATMENT DATA
Date Received: 06/24/2021 Patient Sequence Number: 1
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