MAUDE Adverse Event Report: MEDTRONIC, INC. MYCARELINK SMART READER; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	25000
Medical Device Problem Code	Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Electric Shock (2554); Swelling/ Edema (4577)
Date of Event	01/13/2021
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 after opening the box for the mobile reader, the patient had a reaction from the odor and it felt like the patient's lips were swelling although they were not swollen.The patient also reported that when taking the monitor out of the box, the patient started getting mild electricity in the hands and when inhaling it could be felt in the body.The patient noted that going into the clinic to have the device checked does not give the patient any reaction.The patient reported having the same reaction to other electronics.The patient was referred to the clinic to discuss and will be returning the monitor.No further patient complications have been reported as a result of this event.

• Brand Name: MYCARELINK SMART READER
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 11223780
• Report Number: 2182208-2021-00346
• Device Sequence Number: 11649019
• Product Code: OSR
• UDI-Device Identifier: 00763000305079
• UDI-Public: 00763000305079
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 25000
• Device Catalogue Number: 25000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1