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

Model Number	3300
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this programmer's touchscreen froze up sporadically.In some instances, the touchscreen froze during a threshold test.The threshold test was not able to end.The programmer was turned off and rebooted, which would resolve the issue.It was noted that this event occurred in various clinics.The programmer is expected to be returned.No adverse patient effects were reported.
Additional Manufacturer Narrative
The device was not returned for product 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.The investigation determined that the cause of touchscreens becoming unresponsive during use was due to the water detection feature within the programmer's liquid crystal display (lcd) touchscreen assembly.Various inputs can induce false positive detections of this water detection feature, which then results in an unresponsive touchscreen.
Event or Problem Description
It was reported that this programmer's touchscreen froze up sporadically.In some instances, the touchscreen froze during a threshold test.The threshold test was not able to end.The programmer was turned off and rebooted, which would resolve the issue.It was noted that this event occurred in various clinics.The programmer is expected to be returned.No adverse patient effects were reported.
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; data review revealed that no error/fault codes had been recorded.The reported clinical observation of a non-responsive touchscreen was not reproduced in the laboratory setting.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.Investigation determined that the cause of the touchscreen becoming unresponsive during use was due to the water detection feature within the programmer's lcd touchscreen assembly.The purpose of this water detection feature is to detect the presence of water on/near the programmer screen.If water is detected, this feature is designed to disable the touchscreen to prevent water droplets from causing false positive touch inputs during use.Specifically, the investigation determined that various inputs could induce false positive detections of this water detection feature, which then results in an unresponsive touchscreen.The device was not returned for product 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.The investigation determined that the cause of touchscreens becoming unresponsive during use was due to the water detection feature within the programmer's liquid crystal display (lcd) touchscreen assembly.Various inputs can induce false positive detections of this water detection feature, which then results in an unresponsive touchscreen.
Event or Problem Description
It was reported that this programmer's touchscreen froze up sporadically.In some instances, the touchscreen froze during a threshold test.The threshold test was not able to end.The programmer was turned off and rebooted, which would resolve the issue.It was noted that this event occurred in various clinics.The programmer is expected to be returned.No adverse patient effects were reported.Subsequently, the programmer was returned.

• 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: 19405959
• Report Number: 2124215-2024-32285
• Device Sequence Number: 15394227
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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: Other
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 009624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 09/25/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/11/2024; 09/25/2024
• 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