MAUDE Adverse Event Report: PLEXUS LATITUDE PROGRAMMING SYSTEM; EXTERNAL PROGRAMMER

Model Number 3300

Device Problems Pacing Problem (1439); Device Sensing Problem (2917)

Patient Problem Asystole (4442)

Event Date 12/14/2020

Event Type  malfunction  

Event Description

It was reported that during a cardiac resynchronization therapy pacemaker (crt-p) system implant interrogation, this interrogation was prematurely ended via this programmer.Subsequently, no pacing was delivered resulting in asystole.This patient was noted to be pacing dependent.No additional adverse patient effects were reported.

Event Description

During the implant procedure, this programmer was used to interrogate the associated cardiac resynchronization therapy pacemaker (crt-p) and to perform lead testing using the programmer's built-in pacing system analyzer (psa) application, which can provide both lead testing and backup pacing support during the implant procedure via a psa cable connected to the implanted lead.The physician started by implanting and positioning the right ventricular (rv) lead.The programmer's psa application was used to provide backup pacing via the rv lead, if needed, while the lv and ra leads were subsequently implanted.While attempting to implant the lv lead, it was noted that the patient developed heart block and the psa appropriately began providing backup rv pacing support, as expected.The physician was unable to implant the lv lead and elected to implant a dual chamber pacemaker instead of a crt-p (the pacemaker does not utilize an lv lead).Therefore, a new programmer session was initiated to interrogate the pacemaker.During this time, it was noted that the patient was in asystole for appropriately 2 to 3 seconds.When the asystole was noted, the physician reestablished the psa cable connection to the rv lead, and the psa pacing support then resumed.No additional problems were reported during the procedure, and the pacemaker and associated leads were successfully implanted.Following the procedure, the local boston scientific (bsc) representative contacted bsc technical services (ts) for more information.The psa application is designed to continue providing backup pacing when the programmer application is switched from one device to another (i.E., when the session with the crt-p was ended and the session with the pacemaker began).As a result, testing was performed to determine if any programmer issues may have contributed to the brief asystole that occurred during the procedure and to see if the scenario could be replicated.No issues were identified during this testing process, and it was confirmed that the psa continued to appropriately provide backup pacing during the testing process.The programmer continued to operate normally, and as a result, it remained in service at the facility following this event.As noted above, the psa pacing support resumed after the physician re-established the psa cable connection with the rv lead.Because no problems with the programmer and integrated psa application were identified, it is suspected that the psa cables may have become briefly and inadvertently disconnected from the rv lead, resulting in the 2-3 seconds of asystole.Once the psa cable connection was re-established, psa pacing support resumed, and no additional problems were reported.

Manufacturer Narrative

This programmer was returned to boston scientific for an unrelated reason.Upon receipt at our post market quality assurance laboratory, this programmer was thoroughly inspected and analyzed.Visual inspection found no defects.This programmer was subjected to and passed all system function testing.The pacing system analyzer (psa) was also tested and confirmed to be operational.This programmer was determined to have met all safety and performance specifications, and no problems were identified during the testing process that would have cause or contributed to the clinical event.

• Brand Name: LATITUDE PROGRAMMING SYSTEM
• Type of Device: EXTERNAL PROGRAMMER
• Manufacturer (Section D): PLEXUS; 2400 millbrook dr; buffalo grove IL 60089
• 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: 12285051
• MDR Text Key: 265348981
• Report Number: 2124215-2021-23505
• Device Sequence Number: 1
• Product Code: OSR
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3300
• Device Catalogue Number: 3300
• Device Lot Number: 014889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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