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

Model Number	24950J
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
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 the remote monitor was hot to touch that it left marks on the nightstand.No troubleshooting was taken.The monitor is expected to be replaced.No patient complications have been reported as a result of this event.
Event or Problem Description
The monitor was returned and replaced.
Additional Manufacturer Narrative
Product analysis: model: 24950j, serial/lot#: (b)(4): the remote monitor was returned and analysis revealed that the radio frequency (rf) head battery was defective during functional test.The unit was charged for one hour and error codes 2300 and 5704 were found in the failure analysis (fa) log.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 12211867
• Report Number: 2182208-2021-02921
• Device Sequence Number: 2826466
• Product Code: NVZ
• UDI-Device Identifier: 00643169705746
• UDI-Public: 00643169705746
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 10/27/2021

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: 24950J
• Device Catalogue Number: 24950J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR