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

Model Number	3300
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978); Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Codes	Dizziness (2194); No Patient Involvement (2645)
Date of Event	07/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Following return and completion of laboratory analysis, this event will be further updated.
Event or Problem Description
Boston scientific received information that during in-office threshold testing, the display screen became unresponsive and did not allow the physician to end the threshold testing when required.As a result, the patient was absent of pacing longer than expected and became dizzy.This programmer is no longer in use at this facility and has since been collected for analysis; no data had been saved for review prior to the returned product analysis.Another programmer of different model type was used to complete the office examination.The field later reported that this was the first time this unit had been unresponsive and no telemetry issues were observed.
Additional Manufacturer Narrative
Upon receipt at the manufacturing facility laboratory, this communicator was thoroughly inspected and analyzed.Visual inspection of the system identified no anomalies.The unit passed all system functional and baseline evaluation testing.The log and session files were extracted and checked for an error log and halt (elh); none found.Additional testing was performed for over 12 hours to test for touchscreen unresponsiveness.This testing was inconclusive as the operations were normal.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.
Event or Problem Description
Boston scientific received information that during in-office threshold testing, the display screen became unresponsive and did not allow the physician to end the threshold testing when required.As a result, the patient was absent of pacing longer than expected and became dizzy.This programmer is no longer in use at this facility and has since been collected for analysis; no data had been saved for review prior to the returned product analysis.Another programmer of different model type was used to complete the office examination.The field later reported that this was the first time this unit had been unresponsive and no telemetry issues were observed.
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.Additionally, the touchscreen was tested for functionality and calibration; no anomalies were observed.No error or fault codes were recorded in the programmer's logfile and benchtop testing was unable to reproduce the behavior.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 during an in-office threshold testing, the display screen became unresponsive and did not allow the physician to end the threshold testing when required.As a result, the patient was absent of pacing longer than expected and became dizzy.This programmer is no longer in use at this facility and has since been collected for analysis; no data had been saved for review prior to the returned product analysis.Another programmer of different model type was used to complete the office examination.The field later reported that this was the first time this unit had been unresponsive, and no telemetry issues were observed.

• 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; 2400 millbrook dr; ,; buffalo grove IL 60089
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7979302
• Report Number: 2124215-2018-13744
• Device Sequence Number: 16482016
• Product Code: OSR
• UDI-Device Identifier: 00802526585005
• UDI-Public: 00802526585005
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 000288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 05/02/2019; 06/06/2023
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 06/25/2019; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2017
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown