MAUDE Adverse Event Report: ST. JUDE MEDICAL EP-WORKMATE¿ CATHETER INTERFACE MODULE - 56 CHANNEL; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	100034292
Medical Device Problem Codes	Signal Artifact/Noise (1036); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the atrioventricular nodal re-entrant tachycardia procedure, signals were not visible resulting in cancellation of the procedure.At the beginning of the procedure normal noise appeared, however, a blue line was present while the ecg trace was present and clean.It was only possible to view the signals in navx mode.The system was restarted, the amplifier was directly connected to bypass the recordconnect which did not resolve the issue and the procedure was cancelled with no adverse patient consequences.
Event or Problem Description
Further information received from the reporting person confirmed that the issue was isolated to the workmate catheter interface module.
Additional Manufacturer Narrative
Corrected information: b5, d1, d4, g3, h2.
Additional Manufacturer Narrative
The results of the investigation are inconclusive as the device was inadvertently discarded.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported incident remains unknown.

• Brand Name: EP-WORKMATE¿ CATHETER INTERFACE MODULE - 56 CHANNEL
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15403178
• Report Number: 2184149-2022-00219
• Device Sequence Number: 14716559
• Product Code: DQK
• UDI-Device Identifier: 05415067003126
• UDI-Public: 05415067003126
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100034292
• Device Catalogue Number: 100019209
• Device Lot Number: 6272791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 01/03/2023
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 12/21/2022; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown