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

Model Number	24950LLQ
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/07/2020
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 monitor reader was so hot that it burned the patient's skin when it was placed on the chest.The reader left a burn mark but has disappeared.It was further reported that the reader was hot to the touch; it felt as hot as a burner on the stove.No troubleshooting indicated.The monitor would be returned.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: model: 24950llq, serial/lot#: (b)(4): the monitor was returned and the analysis revealed that no defect was found; the radiofrequency (rf) head was returned with gold contact.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The monitor was 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: 9737052
• Report Number: 3004593495-2020-00176
• Device Sequence Number: 1814767
• Product Code: NVZ
• UDI-Device Identifier: 00763000113995
• UDI-Public: 00763000113995
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/30/2020

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: 24950LLQ
• Device Catalogue Number: 24950LLQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 98