MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE DEVICE

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 10/07/2023

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited noise that was stored as an atrial fibrillation (af) event.Additionally, there was an untreated event.Both times the device was programmed in alternate vector 1x.A chest x-ray was performed, and everything was normal.All three vectors were viewed and there was no evidence of any issues.Auto setup failed in primary due to a few good beats, secondary passed, and alternate passed and was chosen.Technical services (ts) discussed possible causes.The field representative will discuss with the health care professional (hcp).Additional information was received which reported this patient received multiple inappropriate shocks due to noise that was oversensed.Subsequently, the system was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE DEVICE
• 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: 18989513
• MDR Text Key: 338740216
• Report Number: 2124215-2024-18609
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 242441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male