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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 24950M
Medical Device Problem Code Overheating of Device (1437)
Date of Event 03/08/2022
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the remote monitor was hot that it even melted the power cord.No troubleshooting indicated.The monitor is expected to be replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
MYCARELINK PATIENT MONITOR
Common Device Name
PULSE GENERATOR, PERMANENT, IMPLANTABLE
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13768438
Report Number2182208-2022-00784
Device Sequence Number4104514
Product Code NVZ
UDI-Device Identifier00763000414047
UDI-Public00763000414047
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/15/2022
1 Device was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number24950M
Device Catalogue Number24950M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/08/2022
Initial Report FDA Received Date03/15/2022
Date Device Manufactured10/14/2021
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Reuse
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