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

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.

• Brand Name: MEDTRONIC LINQ
• Type of Device: LINQ INSERTABLE CARDIAC MONITOR
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5562997
• MDR Text Key: 42426084
• Report Number: MW5061548
• Device Sequence Number: 1
• Product Code: DSI
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR