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

Model Number	3300
Medical Device Problem Codes	Defective Device (2588); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt.Detailed analysis determined the error codes seen in the field were the result of a software issue.It was determined the code indicated the software update was not downloaded and installed by the programmer properly.The software was reloaded to correct this issue.Similar product behavior has been seen previously, and analysis of those occurrences determined this software issue may result when the model 3300 programmer is attempting to perform an action against a specific feature in the programmer's control center (e.G., multiple application utility or mau) that is no longer available as it was already terminated.This can happen when the programmer is shut down or when "quick starting" another pulse generator (pg) application.This unanticipated event sequence results in the display of an error code, as was seen in this particular case, and the need to restart the programmer to clear the error.
Event or Problem Description
It was reported that this integrated programmer displayed an error code message which was happened several times after restarting.Boston scientific technical services (ts) stated that the cause was a hardware issue involving the electrocardiogram (ecg) board.Ts discussed programmer must be returned for repair.This programmer remains in service.No patient involvement reported.Additional information indicated that the programmer exhibited an error code stating that the pacing system analyzer (psa) encountered an unrecoverable error and pacing output may not be available.Rebooting was performed; however it was not successful.Later after an hour, this prm had normal function to include accessing the psa.
Additional Manufacturer Narrative
Amendment: this event is no longer reportable.Please disregard report 2124215-2025-17949.
Event or Problem Description
It was reported that this integrated programmer displayed an error code message which was happened several times after restarting.Boston scientific technical services (ts) stated that the cause was a hardware issue involving the electrocardiogram (ecg) board.Ts discussed programmer must be returned for repair.This programmer remains in service.No patient involvement reported.Additional information indicated that the programmer exhibited an error code stating that the pacing system analyzer (psa) encountered an unrecoverable error and pacing output may not be available.Rebooting was performed; however it was not successful.Later after an hour, this prm had normal function to include accessing the psa.

• 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: 21678438
• Report Number: 2124215-2025-17949
• Device Sequence Number: 12824265
• Product Code: OSR
• UDI-Device Identifier: 00802526610110
• UDI-Public: 00802526610110
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: 010750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown