MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO EP RECORDING SYSTEM - LSPRO 9900; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	86623
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during a procedure a labsystem pro ep recording system was selected for use.The system is showing instability and freezes very often.Procedure was not able to be completed due to this event and had to be cancelled/rescheduled.No further information was provided.Equipment will be replaced.
Additional Manufacturer Narrative
Based on the available information, boston scientific concludes the reported observation of system locks up/crashes that led to the procedure being cancelled/rescheduled was confirmed through investigational analysis.Product analysis was performed and the pc operated very slowly, the load time for windows was well over 30 minutes, when attempting labsystems software the application failed to load, after attempting to operate the pc the system crashed to a systems fault screen (bsod); consequently, confirming the reported allegation.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that during a procedure a labsystem pro ep recording system was selected for use.The system is showing instability and freezes very often.Procedure was not able to be completed due to this event and had to be cancelled/rescheduled.No further information was provided.Equipment was returned for analysis.

• Brand Name: LABSYSTEM PRO EP RECORDING SYSTEM - LSPRO 9900
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19949155
• Report Number: 2124215-2024-49291
• Device Sequence Number: 15667639
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: (01)08714729935872(11)171017(10)2007551(21)0002007551
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K141185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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
• Operator of Device: Other
• Device Model Number: 86623
• Device Catalogue Number: 86623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown