MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ MEDIA CONVERTER; NO MATCH

Model Number	H700165
Medical Device Problem Codes	Device Remains Activated (1525); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, it was reported that the ep-4 could not stop pacing and the error message "hardware on responding" would display resulting in cancellation of the procedure.When the connection error appeared, the pacing sound made a buzzing sound, the stimulation spike could be seen in the signal line, and the light in the pacing channel was blinking.Troubleshooting included connecting the ep-4 straight to the workmate claris dws, swapping the media converter and analog cable, and exchanging the e-4 stimulator to a new unit but issue persisted.The procedure was not completed.
Event or Problem Description
During an atrial fibrillation procedure, it was reported that the workmate claris media convertors were not communicating with the ep-4 stimulator, resulting in pacing not stopping and the error message "hardware on responding" would display resulting in cancellation of the procedure.When the connection error appeared, the pacing sound made a buzzing sound, the stimulation spike could be seen in the signal line, and the light in the pacing channel was blinking.Troubleshooting included connecting the ep-4 straight to the workmate claris dws, swapping the media converter and analog cable, and exchanging the e-4 stimulator to a new unit but issue persisted.The procedure was not completed.
Additional Manufacturer Narrative
Additional information: b5, d1, d3, d4, g3, h2, h3, h5, h6, h8, h11.The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported communication issue and subsequent cancellation could not be determined.Udi information (d4) and 510k (g3) are not provided within this report as this product (model h700165) is an ous configuration not available in the us and is therefore not referenced in the gudid database.

• Brand Name: WORKMATE¿ CLARIS¿ MEDIA CONVERTER
• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21702499
• Report Number: 2184149-2025-00058
• Device Sequence Number: 8592938
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: (01)05414734030236(10)9057169
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K092913
• 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
• Report Date (Section B): 05/22/2025

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: H700165
• Device Catalogue Number: H700165
• Device Lot Number: 9057169
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WORKMATE¿ CLARIS¿ MEDIA CONVERTER
• Patient Sex: Unknown