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

Model Number A219

Device Problems Signal Artifact/Noise (1036); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609); Patient-Device Incompatibility (2682)

Patient Problem Electric Shock (2554)

Event Date 09/07/2022

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 device's delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please refer to the incident description for more information regarding the specific circumstances of this event.

Event Description

It was reported that during induction testing with this subcutaneous implantable cardioverter defibrillator (s-icd) there was difficulty encountered.During the attempted induction the patient would go back to a normal sinus rhythm very quickly.In attempt to induce ventricular fibrillation (vf), atrial fibrillation (af) was unintentionally induced due to telemetry noise.The shock was unable to be aborted, therefore an inappropriate shock was delivered.This system remains in service.No 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: 15698801
• MDR Text Key: 302806854
• Report Number: 2124215-2022-44418
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 167536
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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