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

Model Number	3300
Medical Device Problem Codes	Defective Device (2588); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this latitude programmer was returned to boston scientific without any reported allegations against its functionality or involvement with any adverse patient effects.Initial analysis identified a product performance issue and detailed testing was performed.
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 programmer was powered on and the logfile was downloaded; the programmer was able to interrogate a test pulse generator device several times, confirming successful communication between the programmer and device.The ecg and pacing system analyzer (psa) functions passed all testing.Additionally, the touchscreen was tested for functionality and calibration; no anomalies were observed.Laboratory analysis was unable to determine how or why the touchscreen became unresponsive.No error or fault codes were recorded in the programmer's 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.
Event or Problem Description
It was reported that this latitude programmer was returned to boston scientific without any reported allegations against its functionality or involvement with any adverse patient effects.Initial analysis identified a product performance issue and detailed testing was performed.
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 programmer was powered on and the logfile was downloaded; the programmer was able to interrogate a test pulse generator device several times, confirming successful communication between the programmer and device.The ecg and pacing system analyzer (psa) functions passed all testing.Additionally, the touchscreen was tested for functionality and calibration; no anomalies were observed.Laboratory analysis was unable to determine how or why the touchscreen became unresponsive.No error or fault codes were recorded in the programmer's 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.

• 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: 16900178
• Report Number: 2124215-2023-22802
• Device Sequence Number: 6819350
• Product Code: OSR
• UDI-Device Identifier: 00802526610110
• UDI-Public: 00802526610110
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 06/19/2023

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: Other
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 010726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/19/2023
• 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