MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ ECG CABLE SET; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700131
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6, h11.One workmate¿ claris¿ ecg cable set was received.Visual inspection revealed several color buttons on the lead connectors were missing.The cable and connector port were free of physical damage.The cable was connected to a test claris amplifier and an ecg (electrocardiogram) simulator.Evaluation testing of the ecg was successful.The ecg cable set was functioning as intended during evaluation.Review of the device history record was not possible as the lot number is unknown.The reported event was not confirmed.Evaluation testing was successful as the ecg cable was functioning as intended.Based on the information and investigation provided to abbott, the root cause remains undetermined.
Event or Problem Description
During an av node ablation procedure, there was noise on surface ecgs and ablation catheter while using the ensite precision mapping system resulting in cancellation of the procedure.The recordconnect was bypassed, but the issue did not resolve.The right leg patch, ecg leads, catheter, and connecting cable were replaced, but the issue did not resolve.The cable management and notch filter were checked, and the system was rebooted, but the issue did not resolve.The procedure was cancelled due to this issue.Later the ecg cable set was replaced and the issue was resolved.
Additional Manufacturer Narrative
The product's lot number could not be obtained, therefore the primary di number is provided (d4), but full udi information is not available.

• Brand Name: WORKMATE¿ CLARIS¿ ECG CABLE SET
• 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: wendy mccarty ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20589395
• Report Number: 2184149-2024-00185
• Device Sequence Number: 6567784
• Product Code: DQK
• UDI-Device Identifier: 05415067001313
• UDI-Public: 05415067001313
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K210392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: H700131
• Device Catalogue Number: H700131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/26/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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