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

Model Number	24950JLQ
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the remote monitor was sitting on the patient¿s bedside table and when the patient entered the room there was a fire.The patient was able to extinguish the fire with a fire extinguisher.The patient had fire damage and home owners insurance denied the claim due to product malfunction.The monitor is being returned for analysis.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the remote monitor model# 24950jlq, serial#: (b)(4) was returned and analyzed.The monitor was received with visible burn marks on the outer enclose.The enclosure bottom and top were fused together.The monitor was powered on and a manual interrogation and transmission was completed.The power supply was measured at 4.86v.Visual inspection revealed exterior burn damage.No visible damage to the base or reader pcba, or other components.In conclusion, the burn damage was observed on the exterior of the monitor and could not confirm the customer's complaint of the monitor starting a fire.No defect found (ok).No abnormality observed that suggested any potential cause related to the complaint.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.

• 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: 6880400
• Report Number: 3004593495-2017-00489
• Device Sequence Number: 19032895
• Product Code: NVZ
• UDI-Device Identifier: 00643169705753
• UDI-Public: 00643169705753
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup,Followup
• Report Date (Section B): 05/24/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 10/23/2017; 04/26/2018
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/30/2017; 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR