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

Model Number	24950JLQ
Medical Device Problem Codes	Device Emits Odor (1425); Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
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 patient claimed there had been a house fire in (b)(6) and was told by the fire marshal that the fire was initiated by the remote monitor.The statement was made by the patient and not by the state fire marshal.The patient already discarded the monitor.The monitor replacement status was unknown.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: 7432868
• Report Number: 3004593495-2018-00300
• Device Sequence Number: 1544852
• Product Code: NVZ
• UDI-Device Identifier: 00643169658127
• UDI-Public: 00643169658127
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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: 24950JLQ
• Device Catalogue Number: 24950JLQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR