MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; IMPLANTABLE DEVICE

Model Number G547

Device Problem Difficult to Insert (1316)

Patient Problem Asystole (4442)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

It was reported that during a generator replacement procedure, the physician had difficulties removing the non-boston scientific leads from the old non-boston scientific pulse generator and inserting them into the new cardiac resynchronization therapy defibrillator (crt-d).Ten seconds of asystole were recorded during changeout because of the time to move the leads from the old header to the new.The crt-d system remains in service.No adverse patient effects were reported.

• Brand Name: RESONATE HF CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 18999077
• MDR Text Key: 338941319
• Report Number: 2124215-2024-18663
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: 00802526589744
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 325594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• 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 Age: 67 YR
• Patient Sex: Male