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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC, INC. 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 Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Discomfort (2330)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. The overall baseline gender characteristics is male; the age of the patients was approximately 62 years old. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers. The model listed in the report is a representative of the model family, as there is no specific model listed. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: "implantable cardiac monitors to detect atrial fibrillation after cryptogenic stroke: a systematic review and economic evaluation. " health technology assessment. 2020. 24(5): v-184. Doi: 10. 3310/hta24050. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was reviewed that contained information regarding implantable cardiac monitors (icm) to detect atrial fibrillation (af) after cryptogenic stroke. Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The article reports patients implanted with icms that experienced pain, skin reactions, infection, and pocket erosion which led to device removal. The status/ disposition of the devices is unknown. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.

 
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Brand NameREVEAL LINQ
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10905935
MDR Text Key218514194
Report Number2182208-2020-02989
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 11/25/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
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 Received11/10/2020
Was Device Evaluated By Manufacturer? No Answer Provided
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: 11/25/2020 Patient Sequence Number: 1
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