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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Migration or Expulsion of Device (1395); Invalid Sensing (2293); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)
Patient Problems Syncope (1610); Dyspnea (1816); Undesired Nerve Stimulation (1980); Pain (1994); Shock (2072); Swelling (2091); No Code Available (3191)
Event Date 01/03/2017
Event Type  Malfunction  
Manufacturer Narrative

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

It was reported that the implantable cardiac monitor (icm) patient's "left nipple swell(s) and will stick up and (the patient) will have to push the implant back down. " it was also noted that the device "sends a shock to (the patient's) nipple. " it was noted that the device does not come through the patient's skin. It was also reported that the patient has a "stabbing pain through (their) left nipple" when they lean down. The device remains in use. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

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

 
Event Description

The patient reported that they felt like the implantable cardiac monitor (icm) was "killing" them and also that, when the device was bumped, they had to urinate. They also stated that "the device is entangled with (their) nerves somehow," that their "blood pressure would spike. And then (they would) pass out. " it was further reported that the device was defective and was not accurately detecting their heart rate. The device was explanted.

 
Manufacturer Narrative

Product event summary: the device was returned and analyzed. Returned product analysis was performed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was further reported that the patient's nipple started lactating and "when someone would touch (the patient's) nipple, (they) would defecate. ".

 
Manufacturer Narrative

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

 
Event Description

It was further reported by the patient that there was ". Stuff (left) inside of (them and that). Little pieces (of) black stuff (are) coming out" of the patient's body. They also stated that they the device "caused permanent damage. Now (they) have a lymph chain thing, (that was) starting to invade (their) left lung and (that there were) nodules/nodes forming in (their) lungs. " for which they will see a pulmonologist. It was also stated that they could "hardly breath(e)" and that the implant site still hurts.

 
Manufacturer Narrative

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

 
Event Description

It was further reported that the patient thought that the "doctor did not insert (the icm) correctly. ".

 
Manufacturer Narrative

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

 
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 EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key6782348
MDR Text Key82583637
Report Number9614453-2017-03080
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 CONSUMER
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 06/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date10/28/2017
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/01/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/09/2016
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: 08/09/2017 Patient Sequence Number: 1
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