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

Model Number A219

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Date 07/08/2021

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system oversensed diaphragmatic noise which resulted in an inappropriate shock.The patient experienced discomfort.Muscular noise was reproduced with arm movements, and when the patients arm was upwards the muscular noise that resulted in the inappropriate shock was reproduced.The physician informed that patient to not reproduce that arm movement, and the system will continue to be monitored.This s-icd system remains in service.No additional adverse patient effects were reported.Additional information was received which indicated technical services (ts) reviewed the stored episodes, and noted that the device was currently programmed to the best sensing configuration due to the patient has low r-wave amplitudes.This s-icd system remains in service.No additional adverse patient effects were reported.Additional information was received which indicated that multiple inappropriate shocks were delivered due to oversensing noise.The physician is evaluating an upgrade to a cardiac resynchronization therapy defibrillator (crt-d), s-icd system revision, or an s-icd system explant.At this time, the s-icd system remains in service.No additional adverse patient effects were reported.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
• 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: 19007350
• MDR Text Key: 338979449
• Report Number: 2124215-2024-19191
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2020
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 236274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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