MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LINQ; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)

Model Number LNQ22

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2021

Event Type  Injury  

Event Description

Due to product packaging design, incorrect product was selected and implanted into patient.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC LINQ
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 11806281
• MDR Text Key: 250228438
• Report Number: MW5101281
• Device Sequence Number: 1
• Product Code: MXC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LNQ22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 102