MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER; GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE

Model Number	H21911
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
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 pulmonary vein isolation procedure, with the patient prepped for the procedure, the ep-4 touchpad did not turn on during set up.A direct connection to the computer was attempted to resolve the issue but it was decided to cancel the case due to no stimulation from the system.There were no adverse patient consequences.
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 the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported cancelled procedure could not be conclusively determined.

• Brand Name: EP-WORKMATE¿ AND WORKMATE¿ CLARIS¿ EP-4¿ TOUCHSCREEN COMPUTER
• Common Device Name: GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8823133
• Report Number: 2184149-2019-00135
• Device Sequence Number: 11398154
• Product Code: JOQ
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092913
• 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): 10/11/2019

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: H21911
• Device Catalogue Number: H21911
• Device Lot Number: 6762542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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