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

Model Number	24952A
Medical Device Problem Code	Moisture Damage (1405)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the remote monitor was hot to the touch and was sticky under the base.It was stated that its either a melting paint or the plastic started to melt.No troubleshooting indicated.The remote monitor is expected to be replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
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
• 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: 13018835
• Report Number: 2182208-2021-04940
• Device Sequence Number: 4803182
• Product Code: NVZ
• UDI-Device Identifier: 00763000014384
• UDI-Public: 00763000014384
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/16/2021

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: 24952A
• Device Catalogue Number: 24952A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/16/2021
• Date Device Manufactured: 05/09/2018
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female