MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE CLARIS SYSTEM CATHETER INTERFACE MODULE 1-56 CHANNELS; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700088
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
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
During a his ablation procedure, it was noted there were no ablation signals on the recording system resulting in a delay to the procedure.Troubleshooting included restarting the recording system, reopening the study, restarting the amplifier, and changing the catheter interface module, the egm cable, the catheter and the generator.None of the troubleshooting resolved the issue.The patient was moved to a different room and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be determined.In addition to the room change, the communication issue was resolved by connecting a ground cable between the cim reference and the ablation pin connection.

• Brand Name: WORKMATE CLARIS SYSTEM CATHETER INTERFACE MODULE 1-56 CHANNELS
• 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: 10695092
• Report Number: 2184149-2020-00167
• Device Sequence Number: 11500577
• Product Code: DQK
• UDI-Device Identifier: 05415067000880
• UDI-Public: 05415067000880
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: Health Professional
• Device Model Number: H700088
• Device Catalogue Number: H700088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 10/18/2020
• Supplement Report FDA Received Date: 11/18/2020
• 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