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

Model Number AFD0062

Device Problem Loss of Threshold (1633)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

One workmate¿ claris¿ ep-4¿ cardiac stimulator was received into the lab for analysis. preliminary measurements confirmed system voltages to be within the specified limits and no discoloration of the power supply wiring connector was observed.It was also confirmed that the stimulator successfully executed the post (power on self-test) and communicated with the ep-4 touchscreen pc.The returned cardiac stimulator was then subjected to an extended pacing test which resulted in the loss of communication reported.Additional testing isolated the root cause of the communication issue to the single board compute.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No rework or non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the reported communication issue was isolated to abnormal functionality of the microprocessor.

Event Description

During the procedure, the ep-4 was intermittently stopped pacing after administering adenosine while the patient was in atrial block.While intermittent pacing occurred the screen of the stimulator was show that the unit was still on.After pacing returned, the system would return to the home screen in the middle of the procedure.When pacing returned, the procedure was able to be completed with no adverse patient consequences.

• Brand Name: WORKMATE CLARIS EP-4 CARDIAC STIMULATOR
• 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: 12347536
• MDR Text Key: 267434316
• Report Number: 2184149-2021-00249
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFD0062
• Device Lot Number: 7061297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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