MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number H700123

Device Problems Loss of Threshold (1633); Application Program Version or Upgrade Problem (2881)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation revealed that after the workmate claris (b)(4) software upgrade, the workmate claris dws screen turns black/blank and the user needs to reboot the system to regain functionality.

Event Description

During the procedure, there was intermittent pacing and capture.At the start of the case, all 4 pacing channels were selected and assigned to specific poles.Channel 2 was selected first.Pacing behaved as expected.Channel 1 was selected next and pacing appeared to be occurring, but there were only pacing spikes, no capture.Channel 1 was then unassigned and reassigned back to the same pacing site as the original channel 1 site.Pacing began again and the issue was resolved.There was no change in output or catheter location.There were no adverse consequences to the patient.The cause was attributed to a recent upgrade to windows 10 operating software.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11855277
• MDR Text Key: 251690414
• Report Number: 2184149-2021-00177
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H700123
• Device Catalogue Number: H700123
• Device Lot Number: 7634027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2184149-05/05/21-001-R
• Patient Sequence Number: 1