MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G447

Device Problems Pacing Problem (1439); Under-Sensing (1661)

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

Event Date 04/13/2024

Event Type  malfunction  

Event Description

It was reported that an alert was received in the remote home monitoring system for this cardiac resynchronization therapy defibrillator (crt-d) indicated that crt pacing was less than 90 percent with overall right ventricular (rv) and left ventricular (lv) pacing being 98 percent.Review of presenting and stored electrograms (egms) noted undersensing of atrial signals causing native conduction to occur without the trigger of the sensed av delay.Further review was recommended to the physician.No further assistance was requested.No adverse patient effects were reported.This device remains in service.If pertinent information is provided in the future, a supplemental report will be submitted.

• Brand Name: RESONATE X4 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: 19130207
• MDR Text Key: 340568673
• Report Number: 2124215-2024-23404
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2023
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 253147
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2021
• 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: 53 YR