MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LATITUDE PROGRAMMING SYSTEM; EXTERNAL PROGRAMMER

Model Number	3300
Medical Device Problem Codes	Defective Device (2588); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this programmer had a red warning screen.This occurred after exiting the subcutaneous implantable cardiac defibrillator software application.A device had just been successfully interrogated, and the clinic was closing down the programmer for the day.The local representative tried to interrogate a different device and got the same warning screen.Technical services requested that the programmer be returned.There were no adverse patient effects.The programmer will be returned.
Event or Problem Description
This supplemental report is being filed to provide additional information regarding product analysis.It was reported that this programmer had a red warning screen.This occurred after exiting the subcutaneous implantable cardiac defibrillator software application.A device had just been successfully interrogated, and the clinic was closing down the programmer for the day.The local representative tried to interrogate a different device and got the same warning screen.Technical services requested that the programmer be returned.There were no adverse patient effects.The programmer will be returned.
Additional Manufacturer Narrative
The returned programmer was thoroughly inspected and analyzed.The programmer was tested with the system-functional test and passed.Baseline testing of the system functions was done and this testing passed.The programmer memory was analyzed in order to verify the existence of an error log.An error was detected.There was an error in mounting the programmer application, so the system terminated the application forcibly.This is a software issue, and a system reboot is recommended.The programmer was then stressed on multiple tests and never presented a red screen.It powered on correctly and could interrogate the test devices without problems.Laboratory analysis did not identify a root cause because the failure mode observed in the field could not be replicated during analysis.

• Brand Name: LATITUDE PROGRAMMING SYSTEM
• Common Device Name: EXTERNAL PROGRAMMER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): PLEXUS ELECTRONICA S DE RL DE CV; paseo del norte no; 4640 guadalajara; zapopan, jal 45010 ; MX 45010
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 21853572
• Report Number: 2124215-2025-24197
• Device Sequence Number: 12913601
• Product Code: OSR
• UDI-Device Identifier: 00802526620201
• UDI-Public: (01)00802526620201
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: Health Professional
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 027913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown