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

Model Number	H700124
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, there was no sense interval and no sync signal and the case was cancelled.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3 one workmate¿ claris¿ ep-4¿ cardiac stimulator was received for analysis.Visual inspection of the returned stimulator indicated normal wear on the exterior chassis.It was verified all connectors, switches and labels to be free of physical damage.All mounting hardware was secured and all socketed ic (integrated circuit) components were fully seated.Ac power was applied to the ep-4 stimulator which successfully executed the power on self-test.The returned cardiac stimulator passed an extended pacing test without 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 field reported event remains unknown as no abnormalities were identified.The returned product operated as designed during the evaluation period.

• Brand Name: WORKMATE CLARIS SYSTEM DISPLAY PLUS
• 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: 11507986
• Report Number: 2184149-2021-00093
• Device Sequence Number: 2870291
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: H700124
• Device Catalogue Number: H700124
• Device Lot Number: 6519784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1