MYCARELINK PATIENT MONITOR 24950 00763000114015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for MYCARELINK PATIENT MONITOR 24950 00763000114015 manufactured by Medtronic.

Event Text Entries

[142193371] My reveal linq loop recorder or medtronic mycarelink patient monitor would not download and transmit data at night to be sent to my electrophysiologist. It would only transmit manually. My patient monitor needed to be replaced twice. The issue is that this is the 3rd medtronic mycarelink patient monitor unit i've had to be supplied. The previous 2 failed overtime to transmit events automatically, as medtronic advertises. I've lost my confidence that these units are able to accurately record and transmit events which would greatly help in assessing my health condition and getting it resolved. The most recent events which were not transmitted or downloaded by medtronics systems, was a severe event for me personally, and dr. (b)(6) (electrophysiology) was just as incredulous as to why the data was not available to him, even though the medtronic rep who was in the room with us, had access to these transmissions. It is also questionable as to whether information was lost due to the unit not transmitting on a regular basis as medtronic states. The location, set up, and timing of my patient monitor unit had not been changed and nor am i moving away from the unit in the evening. So why is this 3rd monitor now working while the previous 2 failed? I am incredulous to believe that i am the only person with the reveal linq, a product device available in several countries, who works a shift. This problem solving came from the medtronic representative as he guessed as to where the transmitting problem was. With this in mind, my sleep schedule for the shift only accounts for 3 out of 7 days of the week. Leaving 4 days for the unit to download and transmit. Whether or not i recorded multiple events is not the issue, the issue remains that the base unit fail to download and transmit over time. The patient services department was contacted several times, with little support. I had to verbally request another (my 3rd) base unit to be sent out. They did not offer any product service replacement on their own. After a month i am still waiting for medtronic to send packaging to return the 2nd base unit. I eventually had to contact (b)(6), medtronic representatives who were not willing to escalate a problem, define it and then resolve it. I did not appreciate this type of service from a medical company as i am in need of ongoing medical attention as my health depends on critical medical devices. I would like the medtronic mycarelink patient monitor and reveal linq cardiac monitor flagged as a faulty device. Transmissions were not available from medtronic to (b)(6) clinic electrophysiologist dr. (b)(6). Also, data was not being transmitted from my home base unit at night to either medtronic or provider. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085872
MDR Report Key8515371
Date Received2019-04-12
Date of Report2019-04-10
Date of Event2019-03-19
Date Added to Maude2019-04-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameMYCARELINK PATIENT MONITOR
Generic NamePACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS
Product CodeOSR
Date Received2019-04-12
Model Number24950
Catalog Number00763000114015
Lot NumberYDM089461U
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC

Device Sequence Number: 2

Brand NameMYCARELINK PATIENT MONITOR
Generic NamePACEMAKER/ICD/CRT NON IMPLANTED COMPONENTS
Product CodeOSR
Date Received2019-04-12
Model Number24950
Catalog Number00763000114015
Lot NumberYDM089461U
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerMEDTRONIC

Device Sequence Number: 3

Brand NameREVEAL LINQ LOOP RECORDER
Generic NameDETECTOR AND ALARM, ARRHYTHMIA
Product CodeOSR
Date Received2019-04-12
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerMEDTRONIC


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-04-12

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