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

Model Number G547

Device Problem Under-Sensing (1661)

Patient Problem Cardiac Arrest (1762)

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported that this patient experienced cardiac arrest and sent to the hospital.Technical services (ts) reviewed device episode data of this cardiac resynchronization therapy defibrillator (crt-d) system and found that there were multiple stored episodes of ventricular fibrillation (vf) that correlated with this event.During these episodes there was functional under-sensing of the very fine vf which caused a delayed time to therapy.An electric shock was delivered that converted the rhythm.Reprogramming system sensitivity was recommended.No additional adverse patient effects were reported.Currently, this crt-d system remains in service.

• Brand Name: RESONATE HF 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: 18747464
• MDR Text Key: 335872704
• Report Number: 2124215-2024-10302
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 324658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• 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): Life Threatening
• Patient Age: 77 YR
• Patient Sex: Female