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

Model Number	3300
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction to section d, suspect medical device.
Event or Problem Description
It was reported that during a left ventricular (lv) lead threshold test, this programmer would initiate the threshold test and would not be responsive to the commands.Technical services was consulted and advised on performing a live session to further investigate this behavior.No adverse patient effects were reported.This programmer remains in service.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete udi and other product specific information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a left ventricular (lv) lead threshold test, this programmer would initiate the threshold test and would not be responsive to the commands.Technical services was consulted and advised on performing a live session to further investigate this behavior.No adverse patient effects were reported.This programmer remains in service.
Additional Manufacturer Narrative
Correction to section d, suspect medical device.
Event or Problem Description
It was reported that during a left ventricular (lv) lead threshold test, this programmer would initiate the threshold test and would not be responsive to the commands.Technical services was consulted and advised on performing a live session to further investigate this behavior.No adverse patient effects were reported.This programmer remains in service.
Event or Problem Description
It was reported that during a left ventricular (lv) lead threshold test, this programmer would initiate the threshold test and would not be responsive to the commands.Technical services was consulted and advised on performing a live session to further investigate this behavior.No adverse patient effects were reported.This programmer remains in service.
Additional Manufacturer Narrative
The device was not returned for product analysis.Boston scientific performed an investigation with the available information.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.Correction to section d, suspect medical device.

• 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: 22543597
• Report Number: 2124215-2025-48005
• Device Sequence Number: 12881031
• Product Code: OSR
• UDI-Device Identifier: 00802526610202
• UDI-Public: (01)00802526610202
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/15/2025

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: 005881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 10/08/2025; 10/13/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 07/24/2025; 10/15/2025; 10/15/2025
• 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