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

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS 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 SINGAPORE OPERATIONS REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Signal Artifact/Noise (1036); Migration or Expulsion of Device (1395); Over-Sensing (1438); Under-Sensing (1661)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2021
Event Type  malfunction  
Manufacturer Narrative
Product event summary: the device was not returned for analysis, however, performance data collected from the device was received and analyzed. Analysis of the device memory indicated false asystole due to undersensing. Analysis of the device memory indicated oversensing due to electromagnetic interference/noise. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implantable cardiac monitor (icm) detected false pause episodes. It was further reported that the device experienced undersensing r-waves and oversensing noise. It was suggested that the fixation of the reveal linq did not mature yet and that the device was moving inside the pocket. The device remains in use. No patient complications have been reported as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVEAL LINQ
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SN 486056
Manufacturer (Section G)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SN 486056
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11371271
MDR Text Key233240711
Report Number3008973940-2021-00580
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
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 Received02/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-