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

Model Number 3501

Device Problems High impedance (1291); Failure to Convert Rhythm (1540)

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

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that at the initial implant of this electrode and 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 new tv system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Added codes f1908 + f10, per medical review request.

Event Description

It was reported that at the initial implant of this electrode and 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 new tv system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction to: removed patient code ventricular fibrillation per medical review.

Event Description

It was reported that at the initial implant of this electrode and 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 new tv system remains in service.No additional adverse patient effects were reported.

• Brand Name: EMBLEM 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16656149
• MDR Text Key: 312431401
• Report Number: 2124215-2023-15220
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,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: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 228276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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; Hospitalization; Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male