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	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual inspection of the device revealed chipped glass on the lcd touchscreen.Analysis determined the error codes seen in the field were the result of a software issue.Similar product behavior has been seen previously and analysis of those occurrences determined this software issue may result when the model 3300 programmer is attempting to perform an action against a specific feature in the programmer's control center (e.G., multiple application utility or mau) that is no longer available as it was already terminated.This can happen when the programmer is shut down or when "quick starting" another pulse generator (pg) application.This unanticipated event sequence results in the display of an error code, as was seen in this particular case, and the need to restart the programmer to clear the error.An unresponsive touchscreen is a known and anticipated potential hazard that can occur during use of the device which is accounted for in device risk documentation and labeling.Boston scientific has received similar reported events where the latitude programmer screen became unresponsive to touch and a complaint review confirmed that the occurrence of harm associated with these events is low.
Event or Problem Description
It was reported that the programmer touch screen was not responding.The product was returned for analysis/repair.No adverse patient effects were reported.

• 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: 17078010
• Report Number: 2124215-2023-28984
• Device Sequence Number: 6468844
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

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: Health Professional
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 002455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 06/07/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown