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

Model Number H403023

Device Problem Pacing Problem (1439)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission. .

Event Description

Related manufacturing ref: 2184149-2019-00039.Near the end of a premature ventricular contraction (pvc) procedure, the touchscreen computer delivered six stimuli to the patient instead of three inducing ventricular fibrillation.The patient went into ventricular fibrillation and cardioversion was required to stabilize the patient.The procedure was completed successfully and the patient is in stable condition.

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 stimulation issue and subsequent ventricular fibrillation could not be conclusively determined.

Manufacturer Narrative

Additional information: one workmate¿ claris¿ ep-4¿ cardiac stimulator was received for investigation.Ac power was applied to the ep-4 stimulator which successfully executed the power on self-test.Preliminary voltage measurements confirmed system voltages to be within the specified limits.The returned cardiac stimulator was then subjected to and passed an extended pacing test without issue.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 investigation performed and information available to abbott, the cause of the reported stimulation issue and subsequent cardioversion was unable to 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: 8487016
• MDR Text Key: 141042324
• Report Number: 2184149-2019-00040
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2019

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: 6236034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 04/11/2019; 09/18/2019
• Supplement Dates FDA Received: 05/03/2019; 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 75