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

Model Number 24950M

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the remote monitor reader was hot to the chest and burned the patient.No troubleshooting indicated.The monitor remains in use.No patient complications have been reported as a result of this event.

• Brand Name: MYCARELINK PATIENT MONITOR
• Type of Device: 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 Key: 14137723
• MDR Text Key: 289464026
• Report Number: 2182208-2022-01213
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 00763000367800
• UDI-Public: 00763000367800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24950M
• Device Catalogue Number: 24950M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/18/2022
• Date Device Manufactured: 12/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male