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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
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.
Event or Problem Description
During the procedure, the ep4 stimulator was not communicating with the dws and the case was cancelled.Remote troubleshooting was done but the problem persisted.The patient was punctured, but the procedure could not be completed and the case was abandoned.There were no consequences to the patient.
Additional Manufacturer Narrative
One workmate¿ claris¿ ep-4¿ cardiac stimulator was received for evaluation.The field reported event was confirmed as the stimulator was powered on and communication was unable to be established with the test standard touchscreen.Internal inspection verified all preliminary system voltages were within specification.It was confirmed the microprocessor assembly was non-functional.The microprocessor assembly was temporarily replaced with a known-good unit and functionality was restored.Based on the information provided to abbott and the investigation performed, the root cause was isolated to the microprocessor assembly.
Additional Manufacturer Narrative
Additional information: g4, h2, h3, h6.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported communication issue and subsequent cancelation remains unknown.

• 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: 10202937
• Report Number: 2184149-2020-00088
• Device Sequence Number: 948906
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2020

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: 6727102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 11/18/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 09/25/2020; 11/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other