MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE VELOCITY 2 BUTTON SCROLLING USB OPTICAL MOUSE; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 100098175

Device Problems Application Program Problem (2880); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/04/2021

Event Type  malfunction  

Event Description

During a typical atrial flutter ablation procedure, a clinically significant delay occurred due to issues with being able to start the study correctly.The computer was restarted several times and also the amplifier, computer, ep-4 touchscreen, and ep-4 stimulator were all turned off, unplugged, and restarted in that sequence, but the issue remained.Another recording system was used to resolve the issue and there were no adverse consequences to the patient.

Event Description

During a typical atrial flutter ablation procedure, a clinically significant delay occurred due to issues with being able to start the study correctly.The computer was restarted several times and also the amplifier, computer, ep-4 touchscreen, and ep-4 stimulator were all turned off, unplugged, and restarted in that sequence, but the issue remained.Another recording system was used to resolve the issue and there were no adverse consequences to the patient.During further troubleshooting, the issue was traced to the mouse, and when the mouse was replaced, the issues were resolved.

Manufacturer Narrative

Additional information: b5, h2 corrected information: d1, d4, h6.

Manufacturer Narrative

Corrected information: g3 (pma/510(k) #).

Manufacturer Narrative

One ensite velocity¿ 2 button scrolling usb optical mouse was received for evaluation.Visual inspection revealed that the labels and connectors had no physical damage.All of the mounting hardware was secured.The returned mouse was connected to a test standard ensite velocity computer and functionally tested, and no anomaly was observed.The mouse was connected and disconnected several times and no delayed response was observed.The reported complaint of communication/transmission issue could not be confirmed.

• Brand Name: ENSITE VELOCITY 2 BUTTON SCROLLING USB OPTICAL MOUSE
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ST. JUDE MEDICAL; one st. jude medical drive; st. paul MN 55117
• MDR Report Key: 11800942
• MDR Text Key: 251424865
• Report Number: 2184149-2021-00128
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 05415067009777
• UDI-Public: 05415067009777
• Combination Product (y/n): N
• PMA/PMN Number: K160187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100098175
• Device Catalogue Number: H700977
• Device Lot Number: 7580412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/04/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 05/18/2021; 05/25/2021; 08/05/2021
• Supplement Dates FDA Received: 05/25/2021; 05/26/2021; 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1