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

Model Number 24970A

Device Problems Display or Visual Feedback Problem (1184); Device Difficult to Program or Calibrate (1496)

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

Event Date 05/02/2019

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an implant procedure the mobile programmer momentarily lost telemetry with a device. The loss of telemetry occurred after the leads were hooked up to the device. The user was testing the lead parameters and had tested the impedance, sensing, and atrial threshold with difficulty. Then the mobile programmer momentarily lost telemetry with the device that was implanted. The telemetry was re-established and the patient connector was moved closer to the patient. Afterwards, the mobile programmer was able to navigate through the screens on the interrogation but was unable to perform any tests or refresh the interrogation. The mobile programmer then displayed an error message. It was noted that the electrograms (egm) and marker channels were showing appropriately. The session with the device had to be terminated and the device had to be re-interrogated to perform the right ventricular threshold testing and the final programming. The mobile programmer remains in use. No patient complications have been reported as a result of this event.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8605075
• MDR Text Key: 144867474
• Report Number: 3004593495-2019-00448
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/13/2019

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 05/13/2019
• 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?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/02/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/23/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse