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

Model Number	3300
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the case, and while running a threshold tests the programmer froze.The product remains in service.No patient involvement indicated.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
Event or Problem Description
It was reported that during the case, and while running a threshold tests the programmer froze.The product remains in service.No patient involvement indicated.
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory; functional testing and baseline checks were completed.Laboratory analysis was unable to determine how or why the touchscreen became unresponsive during pacing threshold testing.No error or fault codes were recorded in the programmers logfile and benchtop testing was unable to reproduce the behavior.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.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• 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 CORPORATION; 2400 millbrook dr; buffalo grove IL 60089
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15006213
• Report Number: 2124215-2022-25516
• Device Sequence Number: 14052272
• 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): 05/16/2023

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: 009790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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