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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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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); Under-Sensing (1661); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implantable cardiac monitor (icm) experienced noise on a false pause episode. The current ecg did not contain any heart waves which suggested that the icm had moved and is not positioned at the correct location. The icm remains in use. No 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 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 Key11541116
MDR Text Key241430148
Report Number3008973940-2021-00859
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2021
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 Received03/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/17/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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