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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 Migration or Expulsion of Device (1395); Device Sensing Problem (2917)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
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) patient experienced a possible infection at the implant pocket. It was further reported the icm had come half way out of the device pocket and resulted in the icm exhibiting a sensing abnormality. The device was explanted. No further 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 MN 48605 6
SN 486056
Manufacturer (Section G)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore MN 48605 6
SN 486056
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key11331823
MDR Text Key231958702
Report Number2182208-2021-00687
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeJA
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
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
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 Received02/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/21/2020
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: 02/16/2021 Patient Sequence Number: 1
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