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

Model Number 3300

Device Problems Display or Visual Feedback Problem (1184); Device Sensing Problem (2917); Key or Button Unresponsive/not Working (4063)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2019

Event Type  malfunction  

Event Description

It was reported that during an implant procedure, this programmer exhibited noise while using the pacing system analyzer (psa).The cables were removed and placed into a different psa with no further noise observed.During a different procedure the following week it was noted that the programmer screen was frozen.For threshold testing the voltage was set to 5v, however an impedance measurement was unable to be obtained.The threshold was able to decrement however on the screen it still showed 5v although loss of capture was observed on a surface.A different model programmer and psa were used.No adverse patient effects were reported.

Manufacturer Narrative

The device was not returned for product analysis as the programmer remains in service at the healthcare facility.Although the device was not returned for analysis, boston scientific performed an investigation with all available information.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 Description

It was reported that during an implant procedure, this programmer exhibited noise while using the pacing system analyzer (psa).The cables were removed and placed into a different psa with no further noise observed.During a different procedure the following week it was noted that the programmer screen was frozen.For threshold testing the voltage was set to 5v, however an impedance measurement was unable to be obtained.The threshold was able to decrement however on the screen it still showed 5v although loss of capture was observed on a surface.A different model programmer and psa were used.No adverse patient effects were reported.

• 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: 15615557
• MDR Text Key: 306358955
• Report Number: 2124215-2022-41725
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• 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: 007814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1