MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D433

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)

Patient Problems Arrhythmia (1721); Shock (2072)

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

This product remains implanted and has not been returned.As such, physical analysis has not been conducted in our laboratory.As no further information concerning this report is expected our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) device exhibited noise being oversensed.A technical service (ts) consultant reviewed the device data, noting frequent premature ventricular contraction (pvc) treated with anti-tachycardia pacing (atp) and ventricular tachycardia (vt) treated with a 41j shock.Ts provided programming recommendations.The device remains implanted.No adverse patient effects were reported.

• Brand Name: RESONATE EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16499853
• MDR Text Key: 310852137
• Report Number: 2124215-2023-10775
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526588075
• UDI-Public: 00802526588075
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960040/S385
• 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: 03/07/2023

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: 09/18/2021
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 571846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR