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	09/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the ep-4 would not communicate with the system and the procedure had to be cancelled.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator was received into the lab for analysis.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.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.Preliminary voltage measurements confirmed system voltages to be within the specified limits.The returned cardiac stimulator was then subjected to and passed an extended pacing test without issue.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 field reported event cannot be conclusively determined as no abnormalities were identified.The returned product successfully passed an extended pacing test without issue.

• 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: 12551040
• Report Number: 2184149-2021-00297
• Device Sequence Number: 1295541
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 10/13/2021

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: H403023
• Device Catalogue Number: H403023
• Device Lot Number: 6856088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1