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

Model Number A219

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Failure to Select Signal (1582); Inaccurate Synchronization (1609); Unintended Electrical Shock (4018)

Patient Problems Ventricular Tachycardia (2132); Electric Shock (2554)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

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 devices delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please see the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patient received an inappropriate shock at a rate lower than the conditional zone.This shock induced the patient into ventricular fibrillation, however the device was successful in converting this rhythm.It was noted that there were some movement artifacts.Subsequently, the system was reprogrammed to primary vector and remains in service.No additional adverse events.Kn.

Manufacturer Narrative

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 devices delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please see the description for more information regarding the specific circumstances of this event.

Event Description

This supplemental report is being filed to include information that this patient has received an additional inappropriate shock due to t-wave oversensing.System evaluation was performed and all of the sensing vectors were good.Technical services had recommended to increase the conditional zone for the patient.No adverse events.

• 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
• MDR Report Key: 9873625
• MDR Text Key: 184710262
• Report Number: 2124215-2020-00699
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/29/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 246470
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR