• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Autoimmune Reaction (1733); Erosion (1750); Purulent Discharge (1812); Dyspnea (1816); Edema (1820); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Pulmonary Edema (2020); Rash (2033); Swelling (2091); Joint Swelling (2356); Breast Mass (2439); Sweating (2444)
Event Date 08/16/2016
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported by the implantable cardiac monitor (icm) patient that soon after receiving the icm they got an infection and noticed green pus flowing from their implanted device to their stomach. The icm ate a hole in their sternum, their lungs were damaged, they were filling up with fluid and their breathing was affected. Patient also reports a whole body rash, "poisoned lomfatic system", swelling, pain, fevers, night sweats, ten pounds of fluid gain in their entire body and their joints were inflamed and red. Patient also reported that they had developed a tumor in their chest, had brain fog and developed an autoimmune issue. It was further reported that the icm was sticking out from their chest under the skin, "appears to be a hump around their chest area". Patient also reported that they can't work. The icm was explanted and the patient was prescribed a glucocorticoid. It was further reported by the patient that on explant of icm all the effects have began to clear. 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

It was further reported by the implantable cardiac monitor (icm) patient that their skin rash was "still ongoing even after the icm was removed". It was also reported that the icm patient suffered great leg pain.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8437162
MDR Text Key139348447
Report Number9614453-2019-00886
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
Report Date 04/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/28/2017
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/11/2016
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: 03/20/2019 Patient Sequence Number: 1
-
-