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

Model Number	3300
Medical Device Problem Codes	No Display/Image (1183); Date/Time-Related Software Problem (2582); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this integrated programmer displayed black screen during the pacing system analyzer use in a case and exhibited complementary metal-oxide semiconductor (cmos) anomaly.Boston scientific technical services consultant (ts) discussed troubleshooting on cmos and advised to send for repair if recurs.As of this time, this programmer remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This supplemental correction report was created to capture the additional information received which indicates that the screen anomaly exhibited prior to any implantable leads being introduced.The programmer was rebooted, resolved, and operated normally.This observation no longer meets the definition of malfunction as it was confirmed that the programmer was operating normally.Amending mdr decision to mdr=no report.
Event or Problem Description
It was reported that this integrated programmer displayed black screen during the pacing system analyzer use in a case and exhibited complementary metal-oxide semiconductor (cmos) anomaly.Boston scientific technical services consultant (ts) discussed troubleshooting on cmos and advised to send for repair if recurs.As of this time, this programmer remains in service.No adverse patient effects were reported.Additional information received which indicates that the screen anomaly exhibited prior to any implantable leads being introduced.The programmer was rebooted, resolved, and operated normally.This programmer will be returned for analysis.
Event or Problem Description
It was reported that this integrated programmer displayed black screen during the pacing system analyzer use in a case and exhibited complementary metal-oxide semiconductor (cmos) anomaly.Boston scientific technical services consultant (ts) discussed troubleshooting on cmos and advised to send for repair if recurs.As of this time, this programmer remains in service.No adverse patient effects were reported.Additional information received which indicates that the screen anomaly exhibited prior to any implantable leads being introduced.The programmer was rebooted, resolved, and operated normally.This programmer will be returned for analysis.
Additional Manufacturer Narrative
This supplemental correction report was created to capture the additional information received which indicates that the screen anomaly exhibited prior to any implantable leads being introduced.The programmer was rebooted, resolved, and operated normally.This observation no longer meets the definition of malfunction as it was confirmed that the programmer was operating normally.Amending mdr decision to mdr=no report.Revision to the initial mdr in block h6 device codes.This supplemental report was created to capture additional information.The device was not returned for analysis; therefore, a technical analysis could not be performed.Good faith effort attempts were made to try and retrieve the device, however the device will not be returned.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established a risk review was completed and confirmed that the event of device displays error message was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.

• 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: 23905888
• Report Number: 2124215-2025-93346
• Device Sequence Number: 9964603
• Product Code: OSR
• UDI-Device Identifier: 00802526610202
• UDI-Public: (01)00802526610202
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 004179
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 03/16/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/12/2026; 04/01/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown