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

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).

• Brand Name: MYCARELINK PATIENT MONITOR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC INC.
• MDR Report Key: 8739876
• MDR Text Key: 149620895
• Report Number: MW5087657
• Device Sequence Number: 2
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/26/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 24950
• Device Catalogue Number: CE0123
• Device Lot Number: M953350A007
• Was Device Available for Evaluation?: No Answer Provided
• 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