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	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this programmer was unresponsive to touch as the touch screen freezes.Additional information received which indicated that the issue did not occur during implant procedure.This programmer remains in service.No patient involvement.
Additional Manufacturer Narrative
The device was not returned for product analysis.Although the device was not returned for analysis, boston scientific performed an investigation with all available information.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.Investigation of this behavior has not found any commonalities (i.E., device serial numbers, date of the event, date of manufacture, etc.) in the reports received.
Event or Problem Description
It was reported that this programmer was unresponsive to touch as the touch screen freezes.Additional information received which indicated that the issue did not occur during implant procedure.This programmer remains in service.No patient involvement.
Additional Manufacturer Narrative
The device was not returned for product analysis.Although the device was not returned for analysis, boston scientific performed an investigation with all available information.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.Investigation of this behavior has not found any commonalities (i.E., device serial numbers, date of the event, date of manufacture, etc.) in the reports received.This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The programmer was powered on and it was confirmed that the touchscreen was intermittently unresponsive due to not detecting touch inputs.No error or fault codes were recorded in the programmer's logfile.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.Investigation of this behavior has not found any commonalities (i.E., device serial numbers, date of the event, date of manufacture, etc.) in the reports received.

• 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 IL 45010 ; MX 45010
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17288990
• Report Number: 2124215-2023-35899
• Device Sequence Number: 12140042
• Product Code: OSR
• UDI-Device Identifier: 00802526616105
• UDI-Public: 00802526616105
• 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): 12/20/2023

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: 010379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 12/20/2023
• 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