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

Model Number H403023

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

When preparing for the procedure, the ep-4 was off and self test failed which resulted in the cancellation of the procedure as the troubleshooting did not resolve the issue.There was no patient consequences.

Manufacturer Narrative

The results of the investigation were inconclusive since the device was not returned for analysis.It was reported by the field in the communication hub, that the failure was caused by a faulty usb cable.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances associated with the reported event were identified.Based on the information received, the cause of the reported incident was consistent with the reported faulty usb cable.

Event Description

The usb cable was replaced and the issue was resolved.

• Brand Name: WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14802024
• MDR Text Key: 301975301
• Report Number: 2184149-2022-00148
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067001245
• UDI-Public: 05415067001245
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K092913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Catalogue Number: H700124
• Device Lot Number: 5225088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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