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	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the touchscreen of the programmer was not responding during initial powerup, and then the programmer froze up during an left ventricular (lv) threshold test.Technical services (ts) was contacted, and ts recommended replacing the programmer.No adverse patient effects were reported.
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.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.
Additional Manufacturer Narrative
This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual inspection of the device revealed external damage such as chipped glass on the touchscreen.The programmer was powered on and it was confirmed that the touchscreen was intermittently unresponsive due to not detecting touch inputs.Error codes were recorded in the programmers logfile.After re-stressing the programmer, it passed the manual stress test, even though it passed other tests including functional testing and deviation testing.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 the touchscreen of the programmer was not responding during initial powerup, and then the programmer froze up during an left ventricular (lv) threshold test.Technical services (ts) was contacted, and ts recommended replacing the programmer.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 CORPORATION; 2400 millbrook dr; buffalo grove IL 60089
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19211786
• Report Number: 2124215-2024-26002
• Device Sequence Number: 12493327
• Product Code: OSR
• UDI-Device Identifier: 00802526608513
• UDI-Public: 00802526608513
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 008725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 08/18/2024
• 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