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

Model Number	H403023
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an atrial fibrillation procedure, it was reported the ep-4 did not pass the self-test and the procedure was cancelled.The issue was not resolved, the patient taken off the table, and the procedure was cancelled.
Additional Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator pn (b)(6) and sn (b)(6) was received into the lab for investigation.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 operated as designed 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.The root cause of the reported issue could not be confirmed to be a manufacturing, design, or quality system related occurrence.The reported issue will continue to be monitored for trends and reviewed in qdr (quality data review).

• Brand Name: WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR
• 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: 16013505
• Report Number: 2184149-2022-00300
• Device Sequence Number: 20658583
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/19/2023

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: 5899230
• 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: 12/19/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic