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

Model Number H403023

Device Problem Pacing Problem (1439)

Patient Problem Ventricular Fibrillation (2130)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a ventricular tachycardia procedure, the patient went into ventricular fibrillation.The stimulator would not sense and pacing was applied on the r wave causing fibrillation.The patient was required to restore sinus rhythm.The procedure was completed successfully.

Manufacturer Narrative

One workmate¿ claris¿ ep-4¿ cardiac stimulator was returned 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.Functional testing confirmed sensing features operate as per design and intent.Sense level testing was performed during the hardware evaluation and confirmed normal sense functionality.Based on the information provided to abbott and the investigation performed, the root cause of the induced arrhythmia could not be determined.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.

• Brand Name: EP-WORKMATE¿ 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: 8788777
• MDR Text Key: 150965069
• Report Number: 2184149-2019-00130
• Device Sequence Number: 1
• Product Code: DQK
• 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: 10/11/2019

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: 6386966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 10/08/2019
• Supplement Dates FDA Received: 07/31/2019; 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention