MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK SMARTSYNC; ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number	24970A
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
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
It was reported the tablet software would not allow user to adjust pacing rate or mode to set up temporary parameters for lead analysis prior to lead connection.Troubleshooting was attempted including force closing the application and resetting/unplugging the base unit.It was noted the screen had locked up and had an audible click without responding, so the application had to be forced closed.A low battery warning screen also displayed, with brand new batteries, so the batteries were removed and reinstalled, with no success.The rate or mode still could not be adjusted.The screen would only show a very brief hourglass, and the following screen would not populate at all.Only on pacing in the atrium and/or the ventricle was able to be turned on, to which then the analyzer would nominally choose aai, vvi, or ddd modes, and it would pace at the nominal rate of 50 ppm (paces per minute).As a result, there was no way to analyze leads.The mobile programmer application/android set-up was abandoned altogether and the legacy programmer/analyzer used.It was noted again that the low battery warning displayed, so the batteries were removed and new batteries reinstalled.The analyzer was relaunched, but the same previous issues were experienced, and deleting and reinstalling the application was not successful.The mobile programmer application 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.

• Brand Name: CARELINK SMARTSYNC
• Common Device Name: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• MDR Report Key: 6938488
• Report Number: 3004593495-2017-00634
• Device Sequence Number: 891969
• Product Code: DTC
• UDI-Device Identifier: 00643169868540
• UDI-Public: 00643169868540
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K163008
• 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
• Report Date (Section B): 02/08/2018

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: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1