MAUDE Adverse Event Report: ST. JUDE MEDICAL WORKMATE¿ CLARIS¿ FIBER OPTIC CABLE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  malfunction  

Event Description

During a procedure, there were intermittent ep-4 is off or not connected messages resulting in cancellation of the procedure.The ep-4 stimulator was swapped out.While pacing at an interval of 250ms, the pacing could not be halted with the touchscreen or the workmate claris computer.The ep-4 stimulator was power cycled but when powered back on, it resumed pacing.The channels were deselected on the workmate claris but pacing spikes were still displaying.The channel switches on the ep-4 stimulator were turned off but the issue still did not resolve.The entire system was also power cycled but the issue did not resolve.The procedure was then abandoned.After the procedure during troubleshooting replacing the partially broken fiber optic cable causing intermittent connection dropout appears to have resolved the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported connection issue could not be determined.

• Brand Name: WORKMATE¿ CLARIS¿ FIBER OPTIC CABLE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16645952
• MDR Text Key: 312354931
• Report Number: 2184149-2023-00072
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female