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

Model Number	H700123
Medical Device Problem Code	Failure to Analyze Signal (1539)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation results will be provided in a subsequent submission. .
Event or Problem Description
During a diagnostic exploration procedure, the signal leads would not display on the recording system and the procedure was cancelled.The procedure was completed at a different facility.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
A review of the device history record was not possible since the system serial number was provided and the component serial number was not.The results of the investigation are inconclusive since the device was not returned for analysis.Additional information from the field confirmed the system is functional and still in use at the customer facility.Based on the information received, the cause of the reported signal loss and subsequent procedure cancellation 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: 8980860
• Report Number: 2184149-2019-00165
• Device Sequence Number: 19625437
• Product Code: DQK
• UDI-Device Identifier: 05415067001238
• UDI-Public: 05415067001238
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: H700123
• Device Lot Number: 5816016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/08/2019
• 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