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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During an accessory pathway ablation procedure, the stimulator displayed the error message ¿ep-4 stimulator hardware is not connected¿ and the procedure was cancelled.Only the main screen displayed on the touchscreen and it was not possible to change the different stimulation protocols so the procedure was rescheduled.There were no adverse consequences to the patient due to the cancellation.
Additional Manufacturer Narrative
The returned touchscreen pc connected successfully to the external power supply and passed the self-test.No delay or unexpected errors occurred during communication testing and the pc functioned as intended.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.The cause for the communication issue and subsequent procedure cancellation could not be 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: 8288488
• Report Number: 2184149-2019-00013
• Device Sequence Number: 2418684
• Product Code: JOQ
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/04/2019

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: 5995875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/04/2019
• 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