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

Model Number	H403023
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 2184149-2023-00165
• Device Sequence Number: 3454599
• Product Code: DQK
• UDI-Device Identifier: 05414734030236
• UDI-Public: 05414734030236
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown