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

Model Number EP-4I-4-220

Device Problem Pacing Problem (1439)

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Event Description

During procedures, there was an issue with asynchronous pacing due to the ep-4 stimulator not sensing correctly.This resulted in the patient having atrial fibrillation requiring cardioversion.It is reported that the ep-4 stimulator has not sensed properly since the beginning of use.It is used with a non-abbott (bard diagnostic recording system) rather than the workmate claris recording system.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported pacing issue and subsequent arrhythmia could not be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.

• Brand Name: EP-4¿ CARDIAC STIMULATOR AND TOUCHSCREEN
• 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: 18728690
• MDR Text Key: 335711647
• Report Number: 2184149-2024-00034
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/26/2024

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: EP-4I-4-220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2024
• Initial Date FDA Received: 02/18/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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