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

Model Number 24970A

Device Problems Computer Software Problem (1112); Impedance Problem (2950)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2020

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 closed without prompt. The patient connector was successfully connected, and an attempt was made to connect the base to the application but resulted in a closure of the program after base selection but prior to confirmation on the base. It was also reported that whilst using the analyzer to assess the lead, pacing started at 80 beats per minute but no value for lead impedance was displayed after several paced beats. The pacing was terminated and then engaged but no impedance was displayed. The pacing was disengaged and re-engaged for a third time and a value for impedance was then displayed. The programmer remains in use. There was no patient involvement.

• Brand Name: CARELINK SMARTSYNC BASE
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10598473
• MDR Text Key: 208934086
• Report Number: 3004593495-2020-01145
• 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: COMPANY REPRESENTATIVE
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 09/29/2020
• 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: 09/14/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/07/2018
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse