MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE CLARIS EP-4 CARDIAC STIMULATOR; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H403023
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
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, the ep-4 would not establish connection with the claris and the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.The monitor was replaced and the issue was resolved.
Additional Manufacturer Narrative
Additional information: d9, g3, g6, h2, h3, h6.During the procedure, the ep-4 would not establish connection with the claris and the procedure was cancelled.There were no adverse consequences to the patient due to the cancellation.Preliminary measurements confirmed system voltages to be within the specified limits and no discoloration of the power supply wiring connector was observed.It was also confirmed that the stimulator failed to successfully execute the post (power on self-test) and communicate with the ep-4 touchscreen pc, which confirms the reported issue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.Based on the information provided to abbott and the investigation performed, the root cause of the reported communication issue was isolated to abnormal functionality of the microprocessor.

• Brand Name: WORKMATE CLARIS EP-4 CARDIAC STIMULATOR
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11204869
• Report Number: 2184149-2021-00004
• Device Sequence Number: 2914821
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: H403023
• Device Catalogue Number: H403023
• Device Lot Number: 6431936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/10/2021
• 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