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

Model Number 24970A

Device Problems Communication or Transmission Problem (2896); Device Sensing Problem (2917); Impedance Problem (2950)

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

Event Date 10/17/2018

Event Type  Malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the mobile programmer application had lower amplitude waves and impedance measurements than the a different model of programmer. It was also noted that the mobile programmer application lost connection with the device. The mobile programmer application had to be rebooted. 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.

Event Description

It was further reported that there was no active mobile programmer application session while event took place. The analyzer was stopped by the user and then the patient connector lost connection with the application. Then the application was force closed by the user. The originally reported loss of connection was the patient connector losing connection with the application.

• 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: 8056258
• MDR Text Key: 126711246
• Report Number: 3004593495-2018-01080
• 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,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/19/2018

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 11/09/2018
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/11/2018
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse