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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 Hematoma (1884); Unspecified Infection (1930); Pain (1994); Pocket Erosion (2013); Dizziness (2194); Blood Loss (2597)
Event Date 03/28/2017
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers. Patient information is limited due to confidentiality concerns. The gender of the baseline characteristics is male and the baseline age is 74 years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿complications after implantation of a new-generation insertable cardiac monitor: results from the loop study. ¿ international journal of cardiology. 2017; 241:229-234. Http://dx. Doi. Org/10. 1016/j. Ijcard. 2017. 03. 144. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was reviewed that contained information regarding insertable cardiac monitors (icms). Multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers with the available information provided. The author reported that there were seven (7) patients who had procedural dizziness. There were also fifteen (15) patients who showed infections, post-implant pain, ¿minor¿ bleeding, and hematomas; all of which were treated ¿conservatively,¿ or by suturing the wound. For these patients, the device was not explanted. There were nine (9) patients whose device was explanted for the following reasons: infection, post-implant pain, and pocket erosion. Eight (8) of these patients had a new device implanted. The status/location of the icm is unknown. Further follow up did not yet yield any additional information. No further 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, 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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6932369
MDR Text Key88931238
Report Number2182208-2017-01780
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeDA
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 07/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2017
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 Received07/27/2017
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: 10/09/2017 Patient Sequence Number: 1
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