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U.S. Department of Health and Human Services

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

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MEDTRONIC INC. MEDTRONIC LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
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).

 
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Brand NameMEDTRONIC LINQ
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC INC.
MDR Report Key8511004
MDR Text Key142044600
Report NumberMW5085832
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received04/11/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number24960
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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