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

Model Number	3300
Medical Device Problem Codes	Pacing Problem (1439); Defective Device (2588); Device Sensing Problem (2917); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pacing system analyzer (psa) on this integrated programmer was unable to pace or sense in neither of the port.Additionally, left ventricle port pace but noise was noted and screen froze.Technical services (ts) suggested to have the programmer be returned.No patient involvement reported.
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory, including visual inspection, functional and baseline testing, and review of device memory.Analysis confirmed the programmer touchscreen was unresponsive due to not detecting touch inputs.Broken traces were noted on a flexible cable within the touchscreen assembly, which resulted in the clinical observation of an unresponsive touchscreen.An unresponsive touchscreen is a known and anticipated potential hazard that can occur during use of the device which is accounted for in device risk documentation and labeling.Boston scientific has received similar reported events where the latitude programmer screen became unresponsive to touch and a complaint review confirmed that the occurrence of harm associated with these events is low.Investigation of this behavior has not found any commonalities (i.E., device serial numbers, date of the event, date of manufacture, etc.) in the reports received.Investigation determined that the most common cause of the touchscreen becoming unresponsive during use was the water detection feature within the programmer's liquid crystal display (lcd) touchscreen assembly.The purpose of this water detection feature is to detect the presence of water on/near the programmer screen.If water is detected, this feature is designed to disable the touchscreen to prevent water droplets from causing false positive touch inputs during use.Specifically, the investigation determined that various inputs could induce false positive detections of this water detection feature, which then results in an unresponsive touchscreen.Boston scientific's investigation also identified additional potential causes independent of the water detection feature.These include a variety of unrelated root causes such as hardware, environmental, software, and user-related causes that can be intermittent and not reproducible during laboratory analysis.
Event or Problem Description
It was reported that the pacing system analyzer (psa) on this integrated programmer was unable to pace or sense in neither of the port.Additionally, left ventricle port pace but noise was noted and screen froze.Technical services (ts) suggested to have the programmer be returned.No patient involvement reported.

• 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: 22090574
• Report Number: 2124215-2025-34339
• Device Sequence Number: 6926213
• Product Code: OSR
• UDI-Device Identifier: 00802526620201
• UDI-Public: (01)00802526620201
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: Other
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 027923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 10/17/2025
• 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