MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problems High impedance (1291); Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609); Patient-Device Incompatibility (2682)

Patient Problems Atrial Fibrillation (1729); Ventricular Fibrillation (2130)

Event Date 01/11/2023

Event Type  Injury  

Event Description

It was reported that at the initial implant of this subcutaneous implantable cardioverter defibrillator (s-icd), induction into ventricular fibrillation (vf), and conversion were unsuccessful.This patient was noted to be very heavy set.This patient was brought in for defibrillation threshold (dft) testing approximately 2 months later.Induction to vf was unsuccessful yet, induced atrial fibrillation (af).The shock impedance during dft was greater than 100 ohms.Imaging x rays were obtained which looked good.An hour passed and induction was attempted again which failed.The physician opted to attempt to induce vf through placing an electrophysiology (ep) catheter into the right ventricular (rv), via the groin.As the staff prepped for the ep catheter, this patient who was in af, spontaneously went into vf.The first shock failed and the second converted the rhythm.The physician was then successful in placing the ep catheter into rv.Once vf was induced the first, second and third shock failed.Ultimately, the physician opted to explant this s-icd system and implant a transvenous (tv) system.Induction of vf was tested in which a shock successfully converted this patient with the new tv system.The tv system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

Added codes f1908 + f10, per medical review request.

Event Description

It was reported that at the initial implant of this subcutaneous implantable cardioverter defibrillator (s-icd), induction into ventricular fibrillation (vf), and conversion were unsuccessful.This patient was noted to be very heavy set.This patient was brought in for defibrillation threshold (dft) testing approximately 2 months later.Induction to vf was unsuccessful yet, induced atrial fibrillation (af).The shock impedance during dft was greater than 100 ohms.Imaging x rays were obtained which looked good.An hour passed and induction was attempted again which failed.The physician opted to attempt to induce vf through placing an electrophysiology (ep) catheter into the right ventricular (rv), via the groin.As the staff prepped for the ep catheter, this patient who was in af, spontaneously went into vf.The first shock failed and the second converted the rhythm.The physician was then successful in placing the ep catheter into rv.Once vf was induced the first, second and third shock failed.Ultimately, the physician opted to explant this s-icd system and implant a transvenous (tv) system.Induction of vf was tested in which a shock successfully converted this patient with the new tv system.The tv system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Investigation of the available information determined this device's delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please refer to the description for more information regarding the specific circumstances of this event.Added codes f1908 and f10, per medical review request.

Event Description

It was reported that at the initial implant of this subcutaneous implantable cardioverter defibrillator (s-icd), induction into ventricular fibrillation (vf), and conversion were unsuccessful.This patient was noted to be very heavy set.This patient was brought in for defibrillation threshold (dft) testing approximately 2 months later.Induction to vf was unsuccessful yet, induced atrial fibrillation (af).The shock impedance during dft was greater than 100 ohms.Imaging x rays were obtained which looked good.An hour passed and induction was attempted again which failed.The physician opted to attempt to induce vf through placing an electrophysiology (ep) catheter into the right ventricular (rv), via the groin.As the staff prepped for the ep catheter, this patient who was in af, spontaneously went into vf.The first shock failed and the second converted the rhythm.The physician was then successful in placing the ep catheter into rv.Once vf was induced the first, second and third shock failed.Ultimately, the physician opted to explant this s-icd system and implant a transvenous (tv) system.Induction of vf was tested in which a shock successfully converted this patient with the new tv system.The tv system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Removed device code 2406: therapy induced arrhythmia and patient ventricular fibrillation code per medical review.

Event Description

It was reported that at the initial implant of this subcutaneous implantable cardioverter defibrillator (s-icd), induction into ventricular fibrillation (vf), and conversion were unsuccessful.This patient was noted to be very heavy set.This patient was brought in for defibrillation threshold (dft) testing approximately 2 months later.Induction to vf was unsuccessful yet, induced atrial fibrillation (af).The shock impedance during dft was greater than 100 ohms.Imaging x rays were obtained which looked good.An hour passed and induction was attempted again which failed.The physician opted to attempt to induce vf through placing an electrophysiology (ep) catheter into the right ventricular (rv), via the groin.As the staff prepped for the ep catheter, this patient who was in af, spontaneously went into vf.The first shock failed and the second converted the rhythm.The physician was then successful in placing the ep catheter into rv.Once vf was induced the first, second and third shock failed.Ultimately, the physician opted to explant this s-icd system and implant a transvenous (tv) system.Induction of vf was tested in which a shock successfully converted this patient with the new tv system.The tv system remains in service.No additional adverse patient effects were reported.The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Investigation of the available information determined this device's delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please refer to the description for more information regarding the specific circumstances of this event.

• Brand Name: EMBLEM MRI S-ICD
• 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: 16655990
• MDR Text Key: 312429514
• Report Number: 2124215-2023-15219
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 174892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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; Required Intervention; Hospitalization
• Patient Age: 33 YR
• Patient Sex: Male