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

Model Number A219

Device Problem Inaccurate Synchronization (1609)

Patient Problems Atrial Fibrillation (1729); Electric Shock (2554)

Event Date 03/13/2023

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 during induction testing for the patient implanted with this leadless pacemaker and subcutaneous implantable cardioverter defibrillator (s-icd) system, ventricular fibrillation (vf) was induced per protocol.A shock was delivered by the device but the rhythm did not convert to normal sinus rhythm, the shock induced atrial fibrillation (af) instead.Another shock from the device converted the af and restored the patient to normal sinus rhythm.No adverse patient effects were reported.The device remains implanted and in service.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.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.

Event Description

It was reported that during induction testing for the patient implanted with this leadless pacemaker and subcutaneous implantable cardioverter defibrillator (s-icd) system, ventricular fibrillation (vf) was induced per protocol.A shock was delivered by the device but the rhythm did not convert to normal sinus rhythm, the shock induced atrial fibrillation (af) instead.Another shock from the device converted the af and restored the patient to normal sinus rhythm.No adverse patient effects were reported.The device remains implanted and in service.

• 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: 16740536
• MDR Text Key: 313290528
• Report Number: 2124215-2023-17574
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• 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: 179838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male