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

Model Number	H700123
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Prior and during the procedure, interference was noted and the case was cancelled.During the procedure, noise was noted.The cables and electrodes were changed which did not resolve the issue.The procedure was terminated with the presence of parasites.There was no consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the component serial number was not provided.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: WORKMATE CLARIS SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 10839951
• Report Number: 2184149-2020-00200
• Device Sequence Number: 14162655
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: Other
• Device Model Number: H700123
• Device Catalogue Number: H700123
• Device Lot Number: 5538168
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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