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

Model Number H700124

Device Problem Signal Artifact/Noise (1036)

Patient Problem Heart Block (4444)

Event Date 02/02/2021

Event Type  Injury  

Event Description

During a ventricular extra-systole ablation procedure, signal artifact was noted on the electrocardiogram when ablations were delivered which resulted in a right bundle branch block.When ablation was performed near the bundle of his, a right bundle branch block was found afterwards and the procedure was cancelled.No intervention was performed on the patient.The electrodes were noted to have been applied properly.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information received, the cause of the reported heart block could not be determined.

• Brand Name: WORKMATE CLARIS SYSTEM DISPLAY PLUS
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11314833
• MDR Text Key: 231403369
• Report Number: 2184149-2021-00036
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H700124
• Device Catalogue Number: H700124
• Device Lot Number: 5791896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Weight: 37