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

Model Number	24950KLQ
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2018
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 had been leaking a greasy fluid for a week.The patient was advised about monitor replacement.The remote monitor was expected to be replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: model: 24950k, serial/lot#: (b)(4): the remote monitor was returned and analysis revealed foreign material in remote monitor; the remote monitor was stuck on the manufacturer's logo during boot up and had defective lcd (liquid crystal display) module.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: 8072923
• Report Number: 3004593495-2018-01099
• Device Sequence Number: 16685772
• Product Code: NVZ
• UDI-Device Identifier: 00643169725386
• UDI-Public: 00643169725386
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR