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

Model Number	H700124
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11314833
• Report Number: 2184149-2021-00036
• Device Sequence Number: 3692369
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Weight: 37