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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 Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Perforation (2001); Blood Loss (2597); Fluid Discharge (2686)
Event Date 01/01/2015
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. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The baseline gender/age of the patients is male/(b)(6). Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Since no device id was provided, it is unknown if this event has been previously reported. Referenced article: safety profile of a miniaturized insertable cardiac monitor: results from two prospective trials. Pace pacing and clinical electrophysiology. 2015;38(12):1464-1469.

 
Event Description

A journal article was reviewed that contained information regarding implantable cardiac monitors (icms). Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The article reports there were patients who experienced insertion site "superficial wound" infections which did not require treatment, and "minor" bleeding from the insertions site which stopped with applied pressure. There were also patient who experienced insertion site pain; in which some patients had the icm removed. In one patient, a "clear fluid emanated" from the wound, which the physician indicated was not an infection and the icm remained in use. There were two patients who had insertion site infections; one of which also had "mild erythema" and was resolved with antibiotics and one patient whose insertion site was drained and the device was explanted. The article also indicated that there was one patient who experienced pain at the insertion site, which progressed to a "perforation and spontaneous device explant through the insertion site. " the status of all the icms is unknown. No further patient complications have been re ported as a result of this event.

 
Manufacturer Narrative

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

 
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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 Key5711147
MDR Text Key47091999
Report Number2182208-2016-01435
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,Followup
Report Date 03/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/09/2016
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 Received03/01/2016
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: 06/09/2016 Patient Sequence Number: 1
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