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	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this programmer touch-screen keyboard was not working properly that could not select the desired key when tapping the keyboard to enter data.Additional information indicated that the programmer was returned.There was no patient involvement.
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Upon return of programmer, a visual analysis was conducted.No observations found during visual analysis were grounds for reason for return/failure.The programmer failed the system functional testing for a test subset (red lcd test).The unit was powered on, and it was observed that a black spot was present on the screen.Subsequently the programmer was disassembled, where a defective lcd (liquid crystal display) backlight cable was identified through swapping out a known good component and consequent product defect disappearance.However, this is not related to the field observation of unresponsive touchscreen.Field observation of unresponsive touchscreen not confirmed, but despite analysis findings, this investigation is consistent with the criteria for touchscreen unresponsive.

• 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: 18682786
• Report Number: 2124215-2024-07758
• Device Sequence Number: 6205178
• Product Code: OSR
• UDI-Device Identifier: 00802526620201
• UDI-Public: 00802526620201
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2024

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: 028015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/11/2024
• 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