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

Model Number 24970A

Device Problems Device Difficult to Program or Calibrate (1496); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2017

Event Type  Malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK SMARTSYNC
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6938486
• MDR Text Key: 90057377
• Report Number: 3004593495-2017-00635
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K163008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/10/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 04/28/2017
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse