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

Model Number	H403023
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Further information was requested but not received.
Event or Problem Description
During the procedure, a communication issue was noted and the procedure was cancelled.The claris system did not recognize the stimulator and indicated that it was not connected on the claris "stim" menu.The issue could not be resolved and the procedure was abandoned and rescheduled for another day.There were no adverse patient consequences.
Additional Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator was received for evaluation at tech center.Visual inspection of the returned stimulator verified the connectors and labels had no physical damage.The stimulator was powered on and communication was established with the test standard touchscreen.The stimulator passed the self-test for all four channels.The field reported event was not reproducible as stimulator was left-on for an extended period and communication was maintain with no anomaly observed.Functional testing also confirmed consistent stimulation output.The root cause cannot conclusively be determined as the field reported event was not reproducible.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, the root cause cannot conclusively be determined as the field reported event was not reproducible.Communication was established and maintained during the evaluation.

• 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
• MDR Report Key: 10959779
• Report Number: 2184149-2020-00217
• Device Sequence Number: 14255778
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: H700124
• Device Lot Number: 5709287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 02/06/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1