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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INC. REVEAL LINQ DETECTOR AND ALARM ARRYTHMIA

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MEDTRONIC INC. REVEAL LINQ DETECTOR AND ALARM ARRYTHMIA Back to Search Results
Device Problems Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574); Impedance Problem (2950)
Patient Problem Shock from Patient Lead(s) (3162)
Event Date 07/25/2017
Event Type  Injury  
Event Description

Multiple unnecessary shocks, medtronic evra (b)(4), sprint quattro lead fracture, impedance, insertion of reveal linq without consent / knowledge. Sent home with a wires e-devices made in (b)(4) and a bedside "my care link" monitor that alarmed non-stop required explanation. Reported before, yet advisory claims no issues. No notice from medtronic or mfr. Never shown a label from any device. Never warned of potential or actual problems. Believes my care link software was hacked. Was this device serviced by a third party servicer? yes. Fda safety report id# (b)(4).

 
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Brand NameREVEAL LINQ
Type of DeviceDETECTOR AND ALARM ARRYTHMIA
Manufacturer (Section D)
MEDTRONIC INC.
MDR Report Key8671395
MDR Text Key147240894
Report NumberMW5087131
Device Sequence Number3
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
Type of Report Initial
Report Date 05/30/2019
3 DeviceS WERE Involved in the Event: 1   2   3  
1 Patient Was Involved in the Event
Date FDA Received06/04/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
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? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 06/04/2019 Patient Sequence Number: 1
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