MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number D432

Device Problems Pacing Problem (1439); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problems Ventricular Fibrillation (2130); Electric Shock (2554)

Event Date 04/24/2023

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded episodes where anti-tachycardia pacing (atp) was not effective and under sensing was present, which delayed the atp for ventricular fibrillation.An external shock was needed to convert at one of the episodes.Reprogramming options were discussed, and the icd remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESONATE EL ICD VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16972514
• MDR Text Key: 315639476
• Report Number: 2124215-2023-25308
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526588044
• UDI-Public: 00802526588044
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2019
• Device Model Number: D432
• Device Catalogue Number: D432
• Device Lot Number: 225413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• 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 Outcome(s): Other; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male