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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC LINQ LINQ INSERTABLE CARDIAC MONITOR

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MEDTRONIC MEDTRONIC LINQ LINQ INSERTABLE CARDIAC MONITOR Back to Search Results
Model Number LNQ11
Device Problems Shelf Life Exceeded (1567); Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2016
Event Type  Malfunction  
Event Description

Pt received (b)(4) linq recorder. After the procedure during charting, it was noted the outside packaging expired 12/15. Physician and rep notified.

 
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Brand NameMEDTRONIC LINQ
Type of DeviceLINQ INSERTABLE CARDIAC MONITOR
Manufacturer (Section D)
MEDTRONIC
minneapolis MN 55432
MDR Report Key5562997
MDR Text Key42426084
Report NumberMW5061548
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation NURSE
Type of Report Initial
Report Date 04/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/05/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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