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

Model Number G447

Device Problems Battery Problem (2885); Data Problem (3196); High Capture Threshold (3266)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was suspected of overestimating the battery consumption.At follow-up, the day after an unknown rv lead replacement, longevity was only 5 years with consumption 206 percent.The day before, the re-intervention on the lead, the rv output was high at 5v at 0.6ms so consumption was 206 percent and the day before, at the end of procedure, rv output was decreased to 2.5v and consumption had decreased to 118 percent.Data analysis was requested but has yet to begin.The plan is to continue monitoring the patient.No adverse patient effects were reported.This device remains in-service.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) was suspected of overestimating the battery consumption.At follow-up, the day after rv lead replacement, longevity was only 5 years with consumption 206 percent.The day before, the re-intervention on the lead, the rv output was high at 5v at 0.6ms so consumption was 206 percent and the day before, at the end of procedure, rv output was decreased to 2.5v and consumption had decreased to 118 percent.Data analysis was requested but has yet to begin.The plan is to continue monitoring the patient.No adverse patient effects were reported.This device remains in-service.Additional review of device data confirmed there was no evidence of premature battery depletion and no unusual faults or resets and the battery voltage consumption is within expectations based on the therapy programming.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

• 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: 18176971
• MDR Text Key: 328628903
• Report Number: 2124215-2023-65521
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 308608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1