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

Model Number G447

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this patient with a cardiac resynchronization therapy defibrillator (crt-d) device, received inappropriate anti-tachycardia pacing (atp) and 1 inappropriate shock, due to over-sensed noise on the rv lead.A technical service (ts) consultant reviewed device data, noting the noise is seen at the same time every night.The physician advised this is due to the patient using a vibrating plate on his leg at the same time as the events.Ts advised to discontinue using product due to emi interference.The device remains implanted.No adverse patient effects were reported.

• 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: 17021550
• MDR Text Key: 316141952
• Report Number: 2124215-2023-27218
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2019
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 164145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR