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

Model Number	3300
Medical Device Problem Codes	No Display/Image (1183); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this integrated programmer while interrogating and lead threshold testing one half of the screen went black and the other half was kind of frozen.Technical services (ts) recommended return of programmer for repair.No adverse patient effects were reported.This programmer is expected to be returned to boston scientific.
Additional Manufacturer Narrative
At this time, no further information is available.Should additional information become available this report will be updated.
Additional Manufacturer Narrative
Follow up report 1 (correction): this report is being submitted to update section b5 and h6 device codes.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this integrated programmer while interrogating and lead threshold testing one half of the screen went black and the other half was kind of frozen.It was suspected to be related to the software that was not eliciting the pacemaker-based application on the screen.Technical services (ts) recommended return of programmer for repair.No adverse patient effects were reported.This programmer is expected to be returned to boston scientific.
Additional Manufacturer Narrative
The returned programmer was analyzed, passed all tests performed, and exhibited normal device characteristics.Field observation of a display failure, in which half of the screen was not lit and not functioning was not confirmed through return product testing.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.Follow up report 1 (correction): this report is being submitted to update section b5 and h6 device codes.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this integrated programmer while interrogating and lead threshold testing one half of the screen went black and the other half was kind of frozen.It was suspected to be related to the software that was not eliciting the pacemaker-based application on the screen.Technical services (ts) recommended return of programmer for repair.No adverse patient effects were reported.This programmer was already returned to boston scientific.

• 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: 23091372
• Report Number: 2124215-2025-65838
• Device Sequence Number: 9682787
• Product Code: OSR
• UDI-Device Identifier: 00802526610202
• UDI-Public: (01)00802526610202
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/19/2026

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: Lay User/Patient
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 003950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 01/13/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/02/2025; 01/19/2026
• 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