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

Model Number	3300
Medical Device Problem Codes	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	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory; functional testing and baseline checks were completed.The baseline evaluation (series of manual functional tests by a user) was completed, where the unit failed to load the software as intended.This analysis observation is aligned with field observation of software upgrade issues, allegation confirmed.Additionally, the touchscreen was tested for functionality and calibration; no anomalies were observed.The reported clinical observation of a non-responsive touchscreen was not reproduced in the laboratory setting.
Event or Problem Description
It was reported that this programmer exhibited a system issue during ec upgrade, it was unable to connect to bsc update server.Boston scientific technical services (ts) recommend returning programmer for repairs.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: 22021108
• Report Number: 2124215-2025-31056
• Device Sequence Number: 9411964
• Product Code: OSR
• UDI-Device Identifier: 00802526610202
• UDI-Public: 00802526610202
• 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
• Report Date (Section B): 05/14/2025

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: 005647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/14/2025
• 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