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

Model Number A219

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/15/2024

Event Type  Injury  

Event Description

It was reported that the patient had inappropriate shocks after receiving a left ventricular assist device.The patient had three shocks during the procedure due to oversensing of noise.A magnet had been placed over the subcutaneous device during the procedure so the shock electrograms were not stored.This is normal function.The subcutaneous pulse generator sensing vector was set to the secondary vector at the time of the shocks.Technical services advised to reprogram the sensing vector to the alternate vector.This was done successfully.There were no additional adverse patient effects.The system remains implanted.

Event Description

This supplemental report is being filed to provide additional information that the system has been programmed off.There were no additional adverse patient effects.The system remains implanted.It was reported that the patient had inappropriate shocks after receiving a left ventricular assist device.The patient had three shocks during the procedure due to oversensing of noise.A magnet had been placed over the subcutaneous device during the procedure so the shock electrograms were not stored.This is normal function.The subcutaneous pulse generator sensing vector was set to the secondary vector at the time of the shocks.Technical services advised to reprogram the sensing vector to the alternate vector.This was done successfully.There were no additional adverse patient effects.The system remains implanted.

• 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: 18939772
• MDR Text Key: 338113645
• Report Number: 2124215-2024-16815
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 173932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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): Other
• Patient Age: 32 YR
• Patient Sex: Male