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

Model Number	24950KLQ
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Non-healthcare professional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when setting up the internet accessory and sending a manual transmission, the patient stated that the remote monitor was hot, "it has been running hot that you can barely put your hand on it." it was later stated that the remote monitor had cooled off.The remote monitor remains in use.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: model: 24950k, serial/lot#: (b)(4): the remote monitor was returned and analysis revealed that there was no complaint failure found on the remote monitor.Wrong power adapter return; out of electrical specification ; pass using kgu (known good unit )power adapter ; found error code (b)(4) in fa (failure analysis) log.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The monitor was replaced and returned.

• 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: 7741724
• Report Number: 3004593495-2018-00709
• Device Sequence Number: 11160247
• Product Code: NVZ
• UDI-Device Identifier: 00643169725362
• UDI-Public: 00643169725362
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 02/04/2019
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 10/03/2018; 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1