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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that during the implant procedure the implantable cardiac monitor (icm) packaging looked to be compromised with slight damage to the paper seal. The icm was not used. 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 Key12098126
MDR Text Key259347782
Report Number3008973940-2021-02241
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 COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/04/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/01/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/12/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/06/2021
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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