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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC INC. MYCARELINK PATIENT MONITOR PULSE GENERATOR, PERMANENT, IMPLANTABLE

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MEDTRONIC INC. MYCARELINK PATIENT MONITOR PULSE GENERATOR, PERMANENT, IMPLANTABLE Back to Search Results
Model Number 24950
Device Problem Device Sensing Problem (2917)
Patient Problem Loss of consciousness (2418)
Event Date 01/23/2019
Event Type  Injury  
Event Description
Pt has had intermittent communication between reveal linq loop recorder and my carelink transmitting unit since implanted. Medtronic has provided 3 different mycarelink transmitters to pt. Yet again the 3rd updated unit fails to transmit regularly. Whenever pt requested help to troubleshoot the problem, medtronic repeatedly excused it to be an intermittent cell signal over the last 3 years. The medtronic reps, regional mgr and pt service dept were unwilling to escalate the issue to product development technology and/or i. T. Dept even though it was requested on several occasions by the pt over the last 3 years. Medtronic repeatedly stated to the pt as long as it transmits on the regular one-month interrogation, it is considered working. This does not account for the episodes which may have been overwritten in the meantime. The unit would transmit when i would manually download the reveal linq although the dr didn't always receive them until the monthly download. Medtronic sent a 3rd, new updated mycarelink transmitting base in (b)(6) 2019 and again it is failing to transmit regularly on its own after 3 months time. The following were notified of intermittency: cardiologist / ep, device clinic, medtronic rep, pt service dept / mgr, product engineering, regional sales mgr, insurance co, and fda. Passed out at stoplight. Fda safety report id # (b)(4).
 
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Brand NameMYCARELINK PATIENT MONITOR
Type of DevicePULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC INC.
MDR Report Key8739876
MDR Text Key149620895
Report NumberMW5087657
Device Sequence Number1
Product Code LWP
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 06/24/2019
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model Number24950
Device Catalogue NumberCE0123
Device Lot NumberM953350A007
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

Patient Treatment Data
Date Received: 06/26/2019 Patient Sequence Number: 1
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