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	06/26/2020
Type of Reportable Event	Malfunction
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.Laboratory analysis was unable to determine how or why the touchscreen became unresponsive during pacing threshold testing.No error or fault codes were recorded in the programmer's logfile and benchtop testing was unable to reproduce the behavior.
Event or Problem Description
It was reported that the programmer's screen stopped responding when measuring the threshold of a cardiac resynchronization therapy defibrillator (crt-d) patient.The programmer will be returned for repair and analysis.No adverse patient effect was 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.Laboratory analysis was unable to determine how or why the touchscreen became unresponsive during pacing threshold testing.No error or fault codes were recorded in the programmer's logfile and benchtop testing was unable to reproduce the behavior.We have received reports of similar events where the latitude programmer screen became unresponsive to touch inputs during use.In most cases, the programmer required a system reboot to complete testing.Representatives from our post market quality assurance, manufacturing, and design assurance groups are actively investigating this unresponsive touchscreen behavior with the latitude programmer to determine the root cause.Based on our initial investigation, this behavior is most likely design-related.
Event or Problem Description
It was reported that the programmer's screen stopped responding when measuring the threshold of a cardiac resynchronization therapy defibrillator (crt-d) patient.The programmer will be returned for repair and analysis.No adverse patient effect was 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: 15940991
• Report Number: 2124215-2022-51103
• Device Sequence Number: 12372676
• Product Code: OSR
• UDI-Device Identifier: 00802526610110
• UDI-Public: 00802526610110
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 009955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 05/24/2023
• 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 Age: 83 YR
• Patient Sex: Unknown