MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G547

Device Problems Failure to Capture (1081); Device Sensing Problem (2917); Data Problem (3196); Interrogation Problem (4017)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that manual left ventricular (lv) threshold testing was in progess as the physician was closing the device pocket and completing this cardiac resynchronization therapy defibrillator (crt-d) system implant procedure.Telemetry was lost for a moment, and appeared to cancel the threshold test.However instead of returning to the lv threshold test screen, the threshold test continued in the background.The field representative attempted to start a new test in order to interrupt the ongoing threshold test as there was lv loss of capture (loc), but was unsuccessful.The programmer indicated that a test could not be performed because the current diagnostic test was underway.Upon further investigation, the field representative was able to reproduce this observation.When starting a threshold test with marginal telemetry and no loss of telemetry for greater than 2 seconds, press the "end test" button and start another threshold test.While maintaining marginal telemetry throughout, the right timing sequence creates an overlay of the original test and prevents the test from ending.If telemetry had been interrupted for greater than two seconds, or if either stat divert or stat pace had been selected, the test would have ended.This crt-d system remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE HF CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18960429
• MDR Text Key: 338374621
• Report Number: 2124215-2024-17507
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: 00802526589744
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 328621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male