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

Device Problem Pacing Problem (1439)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

During a procedure there was intermittent pacing issues and the procedure was cancelled.No additional information is available.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident could not be determined.

• Brand Name: WORKMATE¿ CLARIS¿ SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15401837
• MDR Text Key: 300055396
• Report Number: 2184149-2022-00218
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1