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

Model Number 3300

Device Problems Device Sensing Problem (2917); Interrogation Problem (4017); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for product analysis because the user was able to resolve the issue and the programmer remains in service at the healthcare facility.Data was provided for review and boston scientific technical services confirmed that the programmer is operating normally.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 implanted subcutaneous implantable cardioverter defibrillator (s-icd) procedure, the physician wanted to test the impedance on the device with a 10 joule synchronous shock, however when performing the test, the device remained in charge.The shock was unable to be delivered and it was not possible to cancel the command on the programmer.The session on the programmer was forced to close and restart since the screen command was not functioning appropriately.The telemetry wand was placed under the patient shoulder near the device when the session was restarted and the telemetry wand was moved above the device when the shock was delivered successfully.It was suspected that an interruption in telemetry caused the programmer to time out on the commanded shock and boston scientific technical services suspects telemetry noise issue.No adverse patient effects were reported.The physician is requesting that the device memory data and programmer log files be evaluated.Data analysis was performed and confirmed that the programmer is operating normally.This programmer remains in-service.

• 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 ELECTRONICA S DE RL DE CV; paseo del norte no; 4640 guadalajara; zapopan, jal 45010 ; MX 45010
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17008311
• MDR Text Key: 316003782
• Report Number: 2124215-2023-26551
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P910077/S159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• 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: 014823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1