MAUDE Adverse Event Report: ST. JUDE MEDICAL EP-4¿ CARDIAC STIMULATOR; EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR

Model Number H403023

Device Problem Pacing Problem (1439)

Patient Problem Arrhythmia (1721)

Event Date 07/25/2023

Event Type  Injury  

Event Description

During a procedure, the pacing interval dropped from 500ms to 100ms on its own, and the patient had to be defibbed.The decrease occurred incrementally over approximately 10 seconds.F5 straight pacing protocol was being used.It was advised that the down arrow key on the keyboard may be stuck.

Manufacturer Narrative

The results of the investigation are undetermined as the device was not returned for analysis.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.Based on the images submitted and information received, the images appear to show a decrease in the stimulation pacing.The cause of the reported arrhythmia remains unknown.

• Brand Name: EP-4¿ CARDIAC STIMULATOR
• Type of Device: EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR
• 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: 17581563
• MDR Text Key: 321513951
• Report Number: 2184149-2023-00165
• 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: K092913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: H403023
• Device Lot Number: 6431945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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; Required Intervention