MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR; CARDIAC CATHETERIZATION MONITORING SYSTEM

Model Number H403023

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

Event Type  Injury  

Event Description

During the procedure with the patient prepped and on the table, the stimulator did not pass the self test resulting in a clinically significant delay.At the beginning of the procedure, the ep-4 stimulator displayed ¿ep-4 is on¿ but did not pass the self test.Troubleshooting included power cycling the stimulator and checking all cable connections but the issue remained.A 60 minute delay occurred while the ep-4 stimulator was being replaced for the procedure to continue.The procedure was completed with no adverse consequences to the patient.

Manufacturer Narrative

One workmate¿ claris¿ ep-4 cardiac stimulator was received for analysis.Visual inspection of the returned stimulator revealed no anomalies.The power on self-test and preliminary voltage measurements were performed which confirmed the returned stimulator passed the internal hardware self-test criteria.It was also confirmed that the stimulator communicated with the ep-4 touchscreen pc successfully upon self-test completion.The stimulator was then subjected to, and subsequently passed, an extended pacing and memory test & numerous power cycles without issue followed by a successful full functional test that met specifications.No self-test failures or communication faults were identified throughout testing as the returned stimulator functioned as intended during investigation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information provided to abbott and the investigation performed, root cause of the reported event could not be conclusively determined as the returned stimulator functioned as intended & no anomalies were identified throughout the investigation.

• Brand Name: WORKMATE¿ CLARIS¿ EP-4¿ CARDIAC STIMULATOR
• Type of Device: CARDIAC CATHETERIZATION MONITORING SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7606443
• MDR Text Key: 111220935
• Report Number: 2184149-2018-00073
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

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
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Lot Number: 5877026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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 Outcome(s): Other