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

Model Number	3300
Medical Device Problem Codes	Use of Device Problem (1670); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Codes	Presyncope (4410); Asystole (4442)
Date of Event	09/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during programmer interrogation of this cardiac resynchronization therapy defibrillator (crt-d) system, loss of capture (loc) was observed during right ventricular (rv) threshold testing for this pacer dependent patient.The health care professional (hcp) attempted to end the test but was unsuccessful.Subsequently, the patient experienced approximately 10 seconds of asystole and nearly passed out.Technical services (ts) discussed troubleshooting options and possible causes, noting that the screen was unresponsive or there was poor telemetry.The hcp performed demo testing and pressed around the programmer screen.The programmer was responsive, which suggested there was likely a poor telemetry connection where the command from the programmer was not recognized by the crt-d.This programmer remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event cause and resolution.At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that during programmer interrogation of this cardiac resynchronization therapy defibrillator (crt-d) system, loss of capture (loc) was observed during right ventricular (rv) threshold testing for this pacer dependent patient.The health care professional (hcp) attempted to end the test, but was unsuccessful.Subsequently, the patient experienced approximately 10 seconds of asystole and nearly passed out.Technical services (ts) discussed troubleshooting options and possible causes, noting that the screen was unresponsive or there was poor telemetry.The hcp performed demo testing and pressed around the programmer screen.The programmer was responsive, which suggested there was likely a poor telemetry connection where the command from the programmer was not recognized by the crt-d.This programmer remains in service.No additional adverse patient effects were reported.Additional information received reported that the programmer was functioning as expected the following as expected the following day.It was suspected that the issue was having two sets of hands on the programmer at the same time, which would not allow the programmer to acknowledge tapping the button to end the test.This programmer remains in service.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during programmer interrogation of this cardiac resynchronization therapy defibrillator (crt-d) system, loss of capture (loc) was observed during right ventricular (rv) threshold testing for this pacer dependent patient.The health care professional (hcp) attempted to end the test, but was unsuccessful.Subsequently, the patient experienced approximately 10 seconds of asystole and nearly passed out.Technical services (ts) discussed troubleshooting options and possible causes, noting that the screen was unresponsive or there was poor telemetry.The hcp performed demo testing and pressed around the programmer screen.The programmer was responsive, which suggested there was likely a poor telemetry connection where the command from the programmer was not recognized by the crt-d.This programmer remains in service.No additional adverse patient effects were reported.Additional information received reported that the programmer was functioning as expected the following day.It was suspected that the issue was having two sets of hands on the programmer at the same time, which would not allow the programmer to acknowledge tapping the button to end the test.This programmer remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for product analysis because the user was able to resolve the issue and the programmer remains in service at the healthcare facility.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.

• 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: 23331066
• Report Number: 2124215-2025-74361
• Device Sequence Number: 12811425
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 003055
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 01/13/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 11/12/2025; 01/27/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown