MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD MYCARELINK PATIENT MONITOR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	24950J
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
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 hand-held unit was quite warm; it was too warm to use comfortably.It was also reported that the monitor was extremely hot and was hotter than the hand-held unit.The patient was reluctant to use the monitor due to the issue.The monitor was unplugged.The monitor remains in use and a replacement power cord will be sent to the patient.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: model: 24950j, serial/lot#: (b)(4): the remote monitor was returned and the analysis revealed that no defect was found; found error codes 2300 and 3230 in the fa (failure analysis) log.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the monitor has been replaced and returned.

• Brand Name: MYCARELINK PATIENT MONITOR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 9108046
• Report Number: 3004593495-2019-00980
• Device Sequence Number: 19643888
• Product Code: NVZ
• UDI-Device Identifier: 00643169705746
• UDI-Public: 00643169705746
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 11/08/2019

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: 10/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 54