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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 Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/12/2021
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

In response to the advisory describing the potential for a partial electrical reset to impact the device¿s ability to detect bradycardia and pause episodes, the implantable cardiac monitor (icm) was prophylactically replaced. No device malfunction was observed while the device was in use, however, given the potential for loss of device functionality, the icm was explanted and replaced to preclude harm to the patient. 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 Key12106715
MDR Text Key259597865
Report Number9614453-2021-02707
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
Report Date 07/14/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/14/2018
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/14/2017
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: 07/02/2021 Patient Sequence Number: 1
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