MAUDE Adverse Event Report: MEDTRONIC INC. MEDTRONIC LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 24960

Device Problem Failure to Transmit Record (1521)

Patient Problem No Information (3190)

Event Date 04/09/2019

Event Type  malfunction  

Event Description

Medtronic linq repeatedly fails to transmit data.Have repeatedly called medtronic.They replaced the transmitter but it continues.What good is a monitor that provides daily data monitoring when it does not upload the data.Medtronic linq does not provide the services it is supposed to be doing.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC LINQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 8511004
• MDR Text Key: 142044600
• Report Number: MW5085832
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 24960
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 104