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

Model Number 3300

Device Problems Device Sensing Problem (2917); Key or Button Unresponsive/not Working (4063)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Although no device has been returned for analysis, we have received reports of similar events, at a low rate of occurrence, where the latitude programmer screen became unresponsive during testing.In most cases, the programmer required a system reboot to complete testing.Our initial investigation of this device behavior has not found any commonalities (i.E., device serial numbers, date of the event, etc.) between the different countries and hospital facilities that reported experiencing this behavior to boston scientific.In addition, attempts to replicate the behavior during testing of those programmers that were returned were unsuccessful.

Event Description

It was reported that the programmers touch screen was unresponsive.The programmer was rebooted, and it was working fine.

• Brand Name: LATITUDE PROGRAMMING SYSTEM
• Type of Device: 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: 16791902
• MDR Text Key: 313799994
• Report Number: 2124215-2023-19241
• Device Sequence Number: 1
• Product Code: OSR
• UDI-Device Identifier: 00802526608513
• UDI-Public: 00802526608513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910077/S159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 008573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1