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

Model Number	3300
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this programmer had an issue with the universal serial bus (usb) ports.Additionally, the usbs were literally frying, and the field representative got a small burn when removing a usb drive.Boston scientific technical services (ts) advised that the programmer should be returned for replacement.As of this time, this programmer remains in service.No patient involvement noted.
Event or Problem Description
It was reported that this programmer had an issue with the universal serial bus (usb) ports.Additionally, the usbs were literally frying, and the field representative got a small burn when removing a usb drive.Boston scientific technical services (ts) advised that the programmer should be returned for replacement.This programmer was enroute for return.No patient involvement noted.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This programmer was thoroughly inspected and analyzed upon receipt.Detailed analysis determined the error codes seen in the field were the result of a software issue.Similar product behavior has been seen previously and analysis of those occurrences determined this software issue may result when the model 3300 programmer is attempting to perform an action against a specific feature in the programmer's control center (e.G., multiple application utility or mau) that is no longer available as it was already terminated.This can happen when the programmer is shut down or when "quick starting" another pulse generator (pg) application.This unanticipated event sequence results in the display of an error code, as was seen in this particular case, and the need to restart the programmer to clear the error.

• 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: 17335214
• Report Number: 2124215-2023-37597
• Device Sequence Number: 15072334
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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: 008525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 12/04/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown