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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 Migration or Expulsion of Device (1395)
Patient Problem Erosion (1750)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers. The overall baseline gender characteristics is 50% female and 50% male; the baseline age of the patients was 39 years old. The baseline weight of the patients is 68 kgs. Please see attached excel file with specific patient/device codes. 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: ¿un-linqed: spontaneous extrusion of newer generation implantable loop recorders. ¿ indian pacing and electrophysiology journal, https://doi. Org/10. 1016/j. Ipej. 2020. 04. 005. If information is provided in the future, a supplemental report will be issued. (b)(4).
 
Event Description
A journal article was reviewed which contained information regarding insertable cardiac monitors (icms). Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers. The article reported that there were four patients whose icm spontaneously extruded within 7-24 days after insertion. Of note, there was no pain reported with any of the extrusions were reported to be pain free, and there were no device or pocket infections noted in any case. 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10166011
MDR Text Key195529718
Report Number2182208-2020-01119
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received05/21/2020
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: 06/17/2020 Patient Sequence Number: 1
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