MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number	09-1462-0056
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation ablation procedure a cancellation occurred due to an amplifier error.When the patient was in the operating room, the amplifier was displaying an alert along with an audible noise.The issue could not be resolved and the procedure was cancelled.There were no adverse patient consequences.
Additional Manufacturer Narrative
One ep-workmate signal conditioning unit was received for evaluation.The ep-workmate scu powered on and successfully established communication with the test standard ep-workmate (dws) system as expected.A basic signal acquisition/quality test which included the surface ecg, baseline, amplitude and stimulus switching were performed and confirmed that the returned amplifier performed within the factory specifications.Communication test was run for several hours and no loss or interrupted communication was observed.The reported amplifier error and subsequent cancellation could not be confirmed.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.

• Brand Name: EP-WORKMATE¿ SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 56 CHANNEL
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8290135
• Report Number: 2184149-2019-00012
• Device Sequence Number: 2701469
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

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: 09-1462-0056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/15/2019
• 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