MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD MYCARELINK SMART MONITOR; PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS

Model Number	25000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Spouse; if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the caller that when the patient placed the reader over the implanted device the patient pulled the reader away while performing a transmission because it felt like it was burning the patient¿s skin.When the patient was asked if the reader was hot to touch, the patient said it was like a match was lit next to her skin.The patient was referred to the clinic and the reader remains in use.No patient complications have been reported as a result of this event.

• Brand Name: MYCARELINK SMART MONITOR
• Common Device Name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 7864761
• Report Number: 3004593495-2018-00865
• Device Sequence Number: 1940030
• Product Code: OSR
• UDI-Device Identifier: 00643169666320
• UDI-Public: 00643169666320
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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: 08/21/2018
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR