MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD MEDTRONIC CARELINK MONITOR (PATIENT HOME MONITOR); PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	2490H10
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
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
The caller reported that the patient stated the remote monitor was getting very hot and was afraid it will start a fire.No troubleshooting taken.The remote monitor is expected to be replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: model#: 2490h10, serial/lot#: (b)(4): the remote monitor was returned, and analysis revealed that there was no complaint failure found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The remote monitor was returned and replaced.

• Brand Name: MEDTRONIC CARELINK MONITOR (PATIENT HOME 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: 9537269
• Report Number: 3004593495-2020-00001
• Device Sequence Number: 19401942
• Product Code: NVZ
• UDI-Device Identifier: 00643169341074
• UDI-Public: 00643169341074
• 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: health professional
• Initial Reporter Occupation: Other Health Care 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: 2490H10
• Device Catalogue Number: 2490H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 01/02/2020
• 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: 81 YR