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	Insufficient Information (4580)
Date of Event	10/26/2020
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.Visual inspection revealed chipped glass on touchscreen and was damaged.The programmer was powered on and the logfile was downloaded.Error code a0ea4d was found during baseline interrogation, related to a software issue.The software application was reloaded and the error disappeared.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 this programmer had an unresponsive touchscreen.The programmer was power cycled several times which did not resolve the issue.The programmer was to be used on a patient who had fallen from a latter and went into ventricular fibrillation (vf) arrest.The vf arrest was unrelated to the programmer and the patient at the time had a pacemaker implanted which could not provide tachy therapy to restore normal sinus rhythm.Two years later the programmer was returned for evaluation.This programmer was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory; functional testing and baseline checks were completed.Visual inspection revealed chipped glass on touchscreen and was damaged.The programmer was powered on and the logfile was downloaded.Error code a0ea4d was found during baseline interrogation, related to a software issue.The software application was reloaded and the error disappeared.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.

• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16998176
• Report Number: 2124215-2023-26049
• Device Sequence Number: 2543711
• Product Code: OSR
• UDI-Device Identifier: 00802526620201
• UDI-Public: 00802526620201
• 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: Other
• Type of Report: Initial
• 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: Lay User/Patient
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 009778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2023
• Initial 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown