MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G424

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Dizziness (2194); Asystole (4442)

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) device experienced an episode of dizziness, and while checking the device during this episode, asystole was observed.The physician sent x-ray images to technical service (ts) for review.Ts advised that the right ventricular (rv) lead was sensing signals marked as rvs which led to the patient experiencing asystole and dizziness.Those signals appeared to come from atrial activity.It was noticed on the x-rays that there was an abandoned pacing lead in the rv and the tip of that lead was very close to the active rv defibrillation lead.This non-boston scientific lead appeared to be conducting atrial activity down to the rv and the active rv defibrillation lead could was sensing it and marking it as rvs.Ts provided programming options and discussed removing the abandoned lead.It was later reported that the physician did not intend to change the programming to avoid oversensing the signals and planned to transfer the patient to another facility for a possible surgical intervention of the non-boston scientific lead.This device remains implanted.

Manufacturer Narrative

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

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) device experienced an episode of dizziness.During interrogation of the device, asystole was observed.The physician sent x-ray images to technical service (ts) for review.Ts advised that the right ventricular (rv) lead was sensing signals marked as rvs which led to the patient experiencing asystole and dizziness.Those signals appeared to come from atrial activity.It was noticed on the x-rays that there was an abandoned pacing lead in the rv and the tip of that lead was very close to the active rv defibrillation lead.This non-boston scientific lead appeared to be conducting atrial activity down to the rv and the active rv defibrillation lead could was sensing it and marking it as rvs.Ts provided programming options and discussed removing the abandoned lead.It was later reported that the physician did not intend to change the programming to avoid oversensing the signals and planned to transfer the patient to another facility for a possible surgical intervention of the non-boston scientific lead.This device remains implanted.Several attempts to obtain the manufacturer and model/serial of the active right ventricular lead have been unsuccessful.Attempts to obtain any additional information regarding this case have been unsuccessful.This investigation will be updated should any further information be provided.

Manufacturer Narrative

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

• Brand Name: RESONATE CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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: 17596946
• MDR Text Key: 321675551
• Report Number: 2124215-2023-45188
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P010012/S436
• 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,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/12/2022
• Device Model Number: G424
• Device Catalogue Number: G424
• Device Lot Number: 499890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other