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

Model Number	2490C15
Medical Device Problem Codes	Overheating of Device (1437); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
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 remote monitor had a burning smell when the patient tried to send a transmission.The patient relocated the monitor in several different places in the home.The monitor is expected to be replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the remote monitor model# 2490c15, serial#: (b)(4) was returned, analyzed and no defect was found.The bench power up test was passed with good power supply, passed full functional test.The tester was unable to simulate the failure.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: CARELINK
• 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: 7089979
• Report Number: 3004593495-2017-00651
• Device Sequence Number: 16372953
• Product Code: NVZ
• UDI-Device Identifier: 00643169334717
• UDI-Public: 00643169334717
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: 2490C15
• Device Catalogue Number: 2490C15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR