MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE CLARIS DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H700150
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During the procedure noise was experienced on the surface signals while pacing and a clinically significant delay occurred.When the physician ablated the slow pathway area for treatment of the avnrt, cs pacing at 500 ms was requested to watch for the av node conduction.With the presence of the high amplitude pacing artifact on surface egms during this case, there were large amplitude surface electrograms timed with both the pacing spike and the qrs.Rf energy was applied to the ablation catheter in the slow pathway area.During the first ablation, the av nodal conduction time was affected.The physician stopped rf ablation within 1.2 seconds of noticing the conduction delay.Av wenckebach was tested with cs pacing and found to be 490 ms, which was 150 ms longer than had been measured at baseline.At this point the physician decided to wait for at least 30 minutes to see if the av nodal conduction time would recover to baseline measurements before deciding how to proceed.Av wenckbache was tested continually during this period at 5-10 minute intervals.After 30 minutes or more, the physician decided to administer isoproterenol.Sinus rate increased and av conduction time decreased after isoproterenol was administered.It was during this waiting time that the physician remarked that the pacing artifact on surface electrograms needed to be fixed because it was interfering with his ability to distinguish qrs complex (and therefore, monitor av conduction).Another attempt was made with rf energy.Cs pacing was performed again.The surface electrogram with the greatest amplitude artifact, lead ii, was removed from the claris live screen to eliminate its obscuring effect on the physiologic responses to pacing.The physician then chose to use focal cryo ablation in the same area until he decided to end the procedure.There was no further intervention needed.The patient was stable at the end of the procedure.The direct cause of the noise remains unknown.
Additional Manufacturer Narrative
One workmate claris amplifier was received for evaluation.The returned workmate claris amplifier was powered on and successful communication was established with the test standard workmate claris computer.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.The communication test was run for several minutes and no interruption or drop in communication was observed.A pace output test was performed by connection the returned claris amplifier to test standard ep-4 stimulator, ecg stimulator, scu pacing test load and 500 ohms load block.The ecg channels and channels 1 and 2 were monitored while the stimulator was on and no spurious signal was observed.The reported complaint of noise artifact and subsequent cancellation could not be confirmed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported noise issue and subsequent delay could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Event or Problem Description
Further information confirmed the amplifier was the suspected cause for the noise and subsequent delay in procedure.

• Brand Name: WORKMATE CLARIS DISPLAY PLUS AMPLIFIER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 9835157
• Report Number: 2184149-2020-00028
• Device Sequence Number: 16926532
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/28/2020

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: H700150
• Device Catalogue Number: H700150
• Device Lot Number: 5744443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/24/2020; 05/21/2020; 06/15/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 05/04/2020; 06/15/2020; 06/28/2020
• 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