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

Model Number	24950KLQ
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
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's reader was smoking.Advised to return reader and the remote monitor.Asked when reader started smoking, patient stated six days ago.The patient stated the night before the monitor was flashing on and off, the patient put a towel over the screen then reader started smoking the next morning.The monitor is expected to be replaced.No patient complications have been reported as a result of this event.

• Brand Name: MYCARELINK
• 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: 7517911
• Report Number: 3004593495-2018-00503
• Device Sequence Number: 13877167
• Product Code: NVZ
• UDI-Device Identifier: 00643169725386
• UDI-Public: 00643169725386
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2018

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: 24950KLQ
• Device Catalogue Number: 24950KLQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR