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

Model Number H403023

Device Problem No Pacing (3268)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  Injury  

Event Description

During an electrophysiology procedure a cancellation occurred due to no pacing.It was not possible to resolve the issue.The procedure was cancelled and rescheduled.There were no adverse patient consequences.

Manufacturer Narrative

One workmate¿ claris¿ ep-4¿ cardiac stimulator was received for evaluation.Power was applied to the returned stimulator and was connected to a known good ep-4 touchscreen and no communication was established, confirming the reported pacing issue.The microprocessor assembly was then temporarily replaced with a known good assembly, communication was successfully established and normal function was restored to the stimulator and a prolonged pacing period was observed, followed by multiple power cycles with no breaks in communication observed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information provided to abbott and the investigation performed, root cause of the pacing issue and subsequent aborted procedure was successfully isolated to abnormal functionality of the microprocessor assembly.

Manufacturer Narrative

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.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported pacing issue and subsequent cancellation could not be determined.

• Brand Name: WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 8156736
• MDR Text Key: 130097342
• Report Number: 2184149-2018-00198
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (y/n): N
• PMA/PMN Number: K151911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Lot Number: 6315485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other