MAUDE Adverse Event Report: MEDTRONIC MYCARELINK; CARDIAC MONITOR

Model Number 24950

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Inoperable (1663)

Patient Problems Scar Tissue (2060); Tissue Damage (2104)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a medtronic reveal linq was implanted inside the pt at (b)(6) hosp in (b)(6).Medtronic sent the transmitter via mail after a week.Pt plugged it in and received no signal.Pt call medtronic.Pt has (b)(6) network and signal has 4 bars but cannot pair the devices (reveal linq and mycarelink).The devices work only on (b)(6) network which is (b)(6).Pt was asked if she has a land line.She has a fiber optic land line but the devices need analog land line.Medtronic is always aware of that but they did not give enough info about the device to the doctors or the patients.Pt cannot operate the devices since then.On (b)(6) 2015, the device was explanted at another hosp.The device migrated from the implant position and it was difficult to take it out.Pt got a big incision and a big scar.Pt went through 2 surgeries for unreliable and inoperable device because medtronic failed to provide enough info to the doctors and the patients.It is preventable and they choose not to tell.

• Brand Name: MYCARELINK
• Type of Device: CARDIAC MONITOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4491554
• MDR Text Key: 5499638
• Report Number: MW5040591
• Device Sequence Number: 2
• Product Code: DSI
• 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: 02/04/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 24950
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2015
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 63