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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 Problems Migration or Expulsion of Device (1395); Unable to Obtain Readings (1516)
Patient Problems Chest Pain (1776); Pain (1994)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. All information provided is included in this report. Patient information is limited due to confidentiality concerns. The model listed in the report is a representative of the model family, as there is no specific model listed. 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: ¿the case of the migrating loop recorder. ¿ jacc march 12, 2019 volume 73, issue 9. Poster contributions. Doi:10. 1016/j. Jaccas. 2019. 06. 020. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was reviewed which contained information about an implantable loop recorder (ilr). The article reported that one week after the ilr was implanted, the patient presented to the emergency department complaining of chest and flank pain. The patient was treated as an ¿acute coronary syndrome¿ and sent home to follow up with the cardiologist the following day. The physician was unable to obtain any data from the ilr. A chest x-ray indicated that the ilr had migrated into the abdominal wall. The patient underwent surgery to remove the ilr. There were no complications and the patient¿s chest and flank pain resolved. The status of the ilr 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 Key9747841
MDR Text Key180862061
Report Number2182208-2020-00359
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,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 02/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/24/2020
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2020
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: 02/24/2020 Patient Sequence Number: 1
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