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

Model Number	3300
Medical Device Problem Codes	No Display/Image (1183); Defective Device (2588); Application Program Problem (2880); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual inspection of the device revealed external damage consistent with the programmer being dropped.The programmer was powered on and it was confirmed that the touchscreen was intermittently unresponsive due to not detecting touch inputs.No error or fault codes were recorded in the programmer's logfile.The programmer was disassembled, and it was determined that the cause of the touchscreen becoming unresponsive during use was due to the water detection feature within the programmer's lcd touchscreen assembly.Various inputs can induce false positive detections of this water detection feature, which then results in 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.
Event or Problem Description
It was reported that this programmer exhibited an upgrade issue.Troubleshooting was performed and the update was completed successfully.However, can't select anything on the screen.As of this time, this programmer remains in service.No patient involvement.
Additional Manufacturer Narrative
Although no device has been returned for analysis, we have received reports of similar events where the latitude programmer screen became unresponsive to touch inputs during use.In most cases, the programmer required a system reboot to complete testing.Representatives from our post market quality assurance, manufacturing, and design assurance groups are actively investigating this unresponsive touchscreen behavior with the latitude programmer to determine the root cause.Based on our initial investigation, this behavior is most likely design related.Supplemental additional information with product return.This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory; functional testing and baseline checks were completed.The programmer was powered on and the logfile was downloaded; data review revealed that there were no instances of error codes were observed.The programmer was able to interrogate a test pulse generator device several times, confirming successful communication between the programmer and device.The ecg and pacing system analyzer (psa) functions passed all testing.Additionally, the touchscreen was tested for functionality and calibration; during an additional stress test of the touchscreen functionality, the touchscreen became unresponsive.Field observation of unresponsive touchscreen confirmed.Representatives from our post market quality assurance, manufacturing, and design assurance groups are actively investigating this unresponsive touchscreen behavior with the latitude programmer to determine the root cause.Based on our initial investigation, this behavior is most likely design related.
Event or Problem Description
As a result of this products return, a visual and functional analysis were completed on the programmer.The programmer was returned and investigated.Field observation of unresponsive touchscreen was confirmed.Broken traces attributing to an unresponsive touchscreen is consistent with capa-00006695.It was reported that this programmer exhibited an upgrade issue.Troubleshooting was performed and the update was completed successfully.However, can't select anything on the screen.As of this time, this programmer remains in service.No patient involvement.

• 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: 21821308
• Report Number: 2124215-2025-22858
• Device Sequence Number: 11814892
• Product Code: OSR
• UDI-Device Identifier: 00802526622908
• UDI-Public: (01)00802526622908
• 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): 08/12/2025

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: 004088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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