MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4 STIMULATOR SYSTEM 110V; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	EP-4-04
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, pacemakers were present during pacing, however, there was no capture.Pacing was done at 10ma/2ms, then increased to 20ma/2ms which did not resolve and pacing could be done on all channels.The stim cables were disconnected and reconnected which did not resolve the issue.The system was power cycled, the bnc cable connection from the ep-4 to the carto system was checked and confirmed to be ok.The issue did not resolve and the procedure was aborted.
Additional Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator was received for investigation.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Normal wear was indicated on the exterior chassis which is consistent with clinical usage.The attenuator in use and blanking setting were not provided for this analysis.The user should confirm synchronization performance during operation and adjust the synchronization sense level, synchronization delay, setup level % parameter and the setup blanking interval if necessary.Performance can be monitored by the synchronization interval and/or monitoring the sense marker output signal on the rear panel of the ep-4¿ cardiac stimulator.The returned cardiac stimulator functioned as anticipated during the evaluation period.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 provided to abbott and the investigation performed, the root cause of the reported event and subsequent cancellation remains unknown.

• Brand Name: EP-4 STIMULATOR SYSTEM 110V
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15496594
• Report Number: 2184149-2022-00237
• Device Sequence Number: 5243219
• Product Code: DQK
• UDI-Device Identifier: 05414734208741
• UDI-Public: 05414734208741
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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: EP-4-04
• Device Catalogue Number: EP-4-04
• Device Lot Number: 8516633
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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