MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EP-4¿ TOUCH SCREEN COMPUTER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H21911
Medical Device Problem Code	No Tactile Prompts/Feedback (4024)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial flutter procedure, the stimulator was unresponsive to a command to stop pacing resulting in the patient experiencing atrial fibrillation which required cardioversion to resolve the atrial fibrillation.The stimulator was turned off and rebooted and the issue was resolved with no further patient consequences.The physician was pacing down to a rate in the 200s, then the stimulator switched to pacing on channel 3 at 340 on its own.When the command to stop pacing was given via the keyboard, it did not stop pacing.It was attempted to stop pacing using the touchscreen but this was also unsuccessful.While this issue was occurring, the system and touchscreen displays showed a green stim bar, indicating the system did not think it was pacing, even though it was.The continued pacing caused the patient to be put into atrial fibrillation.The stimulator was turned off which stopped the pacing.The system was rebooted and the issue was resolved.Cardioversion was performed to resolve the atrial fibrillation.The procedure was completed with no other consequences.
Additional Manufacturer Narrative
One ep-4¿ touch screen computer pn 600073636 and sn 18951737 was received into the lab for analysis.Visual inspection of the returned rf generator confirmed all input/output connector ports are free of physical damage, all labels are intact and legible, and normal wear was indicated on the chassis.The unit is having unexpected touchscreen input.Due to the state of the return, functional testing could not be performed.Based on the information provided to abbott and the investigation performed, the root cause of the field reported event was unable to be determined due to the state of the return.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¿ TOUCH SCREEN COMPUTER
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16948120
• Report Number: 2184149-2023-00107
• Device Sequence Number: 6423219
• Product Code: DQK
• UDI-Device Identifier: 05414734219112
• UDI-Public: 05414734219112
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Report Date (Section B): 05/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: H21911
• Device Catalogue Number: H21911
• Device Lot Number: 7883314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• 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: 04/21/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown