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

Model Number D433

Device Problems Inaccurate Synchronization (1609); Under-Sensing (1661); Use of Device Problem (1670); Data Problem (3196)

Patient Problem Ventricular Fibrillation (2130)

Event Date 03/19/2024

Event Type  Injury  

Event Description

It was reported that multiple ventricular tachycardia (vt) events were noted on this implantable cardioverter defibrillator (icd).The patient was hospitalized for an epicardial ablation and remained in the intensive care unit for monitoring after the procedure.The physicians provided troubleshooting during the hospitalization and attempted to reprogram the device in attempts for the device to provide atp after a shock had been delivered, which is not possible on this icd.Undersensing and a rhythm acceleration to ventricular fibrillation (vf) were noted on the stored episodes.Reprogramming was performed and this icd remains in-service.No additional 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: 18982879
• MDR Text Key: 338641025
• Report Number: 2124215-2024-18308
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/20/2024
• Device Model Number: D433
• Device Catalogue Number: D433
• Device Lot Number: 618759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening