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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 Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/07/2019
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) packaging was perforated and the device was not sterile. The device was not used and replaced. No patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Product event summary: the device was returned and analyzed. Returned product analysis was performed and no anomalies were found. The packaging was extrinsically damaged. 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 SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG 486056
Manufacturer (Section G)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG 486056
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key9196021
MDR Text Key162782130
Report Number3008973940-2019-02822
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK132649
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
Report Date 01/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/28/2020
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/19/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/06/2019
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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